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No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Email * Verify Email Address * Phone . Abbott Park, IL 60064 . REAGENTS Reagent Kit, 100 Tests/500 Tests NOTE: Some kit sizes are not available in all countries or for use on all ARCHITECT i Systems. To share the full Product Catalog, please use the PRODUCT CATALOG > DOWNLOAD option from the navigation bar at the top of the page. First Name. Add to Cart. ARCHITECT TT3 RGT(100T) Product Number 07K6425. We have 88 reagents available for the Abbott Architect, and are always developing more. The Alinity m Resp-4-Plex control reagents are contained in single-use tubes with solid caps. Add to Cart. . Assay for the Detection of HIV p24 Antigen and Antibodies to Human The Centers for Disease Control and Prevention (CDC) advocate voluntary, opt-out HIV screening for all adults in healthcare settings instead of screening only traditionally high-risk patients. I do not want to receive email marketing from Randox. *Use the PRINT, EMAIL and PDF buttons, to the right, to share only this page. Product availability may vary from country to country. If you dont see the application you are looking for, please contact us to request an application. Test will be used on our m2000 RealTime system available in hospitals and molecular labs in the U.S. COVID-19 MOLECULAR TEST ON NEW ALINITY M SYSTEM. If these virus proteins are present, then the patient is likely to be infected with HBV. Click DOWNLOAD to print, email or download the full Product Catalog as a PDF. Carefully follow the package insert instructions. 2018 Sep;55(5):621-622. doi: 10.1177/0004563218780888. 7. Specially formulated to help prevent dehydration by restoring minerals and nutrients lost during diarrhea and vomiting. The ARCHITECT HIV Ag/Ab Combo is not intended for use in screening blood or plasma donors, since the effectiveness of the test for this use has not been established. Intended Use: The ARCHITECT Syphilis TP Assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of antibodies (IgG and IgM) directed against Treponema pallidum (TP) in human serum and plasma. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Objective: To compare and validate the performance of the new Abbott ALINITY i HIV Ag/Ab Combo assay against the current ARCHITECT HIV Ag/Ab Combo. W zawizku z czym firma Randox deklaruje, e bdzie wysyac tylko informacje na temat nowych produktw,akutalizacji obecnych, trendw rynkowych, wydarze branowych itp. Product: ARCHITECT HIV Ag/Ab Combo . Package Insert - Abbott HCV EIA 2.0 ; Supporting Documents. Signing up to our mailing list is quick and easy. ARCHITECT Operations Manual 96211-116. The ARCHITECT HIV Ag/Ab Combo Assay is intended for use as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. Login Abbott Point of Care. | 3 reviews. Fax Number: (224) 667-4836 . Read more in our. This field is for validation purposes and should be left unchanged. NOTE: Changes Highlighted . NOTE: This package insert must be read carefully prior to product use. Approval Date:6/18/2010, An official website of the United States government, : The ARCHITECT i2000 LH, FSH and prolactin results showed excellent correlation with the Abbott AxSYM results, which will enable a laboratory to transfer assays to the new instrument with little or no change in the reference ranges. Approved Blood Products, Recalls, Market Withdrawals and Safety Alerts, Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs), Substantially Equivalent 510(k) Device Information, Package Insert - ARCHITECT HIV Ag/Ab Combo, Package Insert - ARCHITECT HIV Ag-Ab Combo Controls, Package Insert - ARCHITECT HIV Ag/Ab Combo Calibrator, Supporting Documents older than three years - Abbott ARCHITECT HIV Ag/Ab Combo. Talk to your Fisher Heathcare Sales Representative about setting up an early HIV testing initiative in your community using the excellent sensitivity and specificity of the Abbott ARCHITECT HIV Ag/Ab Combo Assay. Read more in our. Signing up to our mailing list is quick and easy. Por favor, introduzca sus datos para ver nuestro ltimo seminario, Rejestracja na naszej licie mailowej jest szybka i atwa. Carefully follow the package insert instructions. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Randox Laboratories promise never to sell your data and we will keep all your details safe and secure. 10697136_EN Rev. United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician. Method: 123 patient's samples, previously . Randox Laboratories promise never to sell your data and we will keep all your details safe and secure. Nutrition for busy people who refuse to sacrifice great taste. Join the Randox Laboratories Mailing List * PDF ARCHITECT BHCG RGT (100T) Product Number 07K7825 ARC TOTAL BHCG RGT 100 TEST Qty Unit: Each Add to Cart Existing customers can access IFUs through Powerline. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in the package insert. For the best experience on our site, be sure to turn on Javascript in your browser. LOINC Code Information. All Rights Reserved. Using the ARCHITECT treponemal tests, labs can increase the likelihood of detecting infections in the primary and latent stages, and will see a decreasing number of false positive results. Dept. Click here to complete the Credit Application if you are a new customer who needs to make a New Business Credit Application to establish a Master Business Account which will establish your Abbott Customer Account, your Bill-To and Ship-To details. ARCHITECT BHCG RGT (100T) *Use the PRINT, EMAIL and PDF buttons, to the right, to share only this page. June 2007 Figure 1: PSA Concentration vs CV% 0 2 4 6 8 10 00 .010 .020 .030 .040 .050 .060 .07 PSA Functional Sensitivity CV % 4.2. We develop a range of applications for the Abbott Architect analyser so that laboratories worldwide can enjoy the benefits of freedom of choice from an independent manufacturer, Randox Laboratories. Refer to the Alinity m Resp-4-Plex CTRL Kit package insert for preparation and usage. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Alinity m EBV is intended for use as an aid in the diagnosis and management of EBV in transplant patients and other immunocompromised patients. First Name. Abbott's life-changing technology helps people live fully and offers information, medicines and breakthroughs to help you manage your health. LOINC was identified by the Health Level 7 (HL7) as a preferred code set for laboratory test names in transactions between healthcare . ARCHITECT System Operations Manual, Section 3. S PCT is CE marked and FDA 510 (k) cleared. Read more in our Privacy Policy. Existing customers can access IFU's through Powerline. 100 Abbott Park Road . Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Original Ref.Code: 6C5560 Packaging: 4x975 mL SKU: 105124 Category: Abbott Architect Brand: Abbott Description . Click here to register for an e-Abbott user account. Read PI05APR2006 LTR doc. i STAT Handheld Blood Analyzer Abbott Point of Care. ARCHITECT ci 16200 Every detail in the ARCHITECT ci 16200 has been designed to handle high-volume, complex workloads. Using the ARCHITECT treponemal tests, labs can increase the likelihood of detecting infections in the primary and latent stages, and will see a decreasing number of false positive results. This single-instrument platform combines both clinical chemistry and immunoassay testing, with analyzers that support labs of all sizes. [table "419" not found /] Customer Support United States: 1-877-4ABBOTT Canada: 1-800-387-8378 (English speaking customers) Potential interference in the Abbott Architect 2nd generation total testosterone assay Ann Clin Biochem. Nutritionally complete, amino acid-based medical food and infant formula with iron. Last Name. Primary contact person for all communications: Judi Wallach, ADD, Regulatory Affairs Project Manager . General Chemistry Analyzers and Accessories, Allergy, Arthritis, and Immunology Testing, Hematology Controls, Callibrators and Standards, Hematology, Histology and Cytology Stains, Histology, Cytology & Anatomical Pathology, General Purpose Laboratory Syringe Accessories, Microbiological Specimen Collection and Transport, https://www.cdc.gov/std/stats15/syphilis.htm, Chemical Storage and Management Resource Center, ARCHITECT Syphilis Package Insert (G5-6810/R01). . Architect Trigger Solutions (4975 mL) Trigger Solutions dedicated to Abbott Architect. If you don't see the application you are looking for, please contact us to request an application. Package insert instructions must be followed accordingly. I could hear him typing, and then he confirmed to me that this lot number 's expiration date had been extended to January 5, 2022. Featuring a load-up capacity of 135 samples with 35 priority and 100 routine areas, the ARCHITECT i 2000SR has 25 refrigerated reagent positions. Manufacturer Abbott. 5.0. | Write your own review. Key to symbols used Reference Number Calibrator A The Abbott ARCHITECT Syphilis Treponemal Test provides an automated method for detecting IgG and IgM antibodies to aid in the diagnosis of syphilis infection. The site is secure. Please sign in to view account pricing and product availability. Telephone Number: (224) 667-1132 . Randox Clinical Chemistry Products Please read the Legal Notice for further details. A reactive result from the ARCHITECT HIV Ag/Ab Combo test does not distinguish between the detection of HIV p24 antigen, HIV-1 antibody, or HIV-2 antibody. Cross reaction between total 25-OH D and 25-OH D2 is the major problem [6]. ABBOTT LAUNCHES NOVEL CORONAVIRUS TEST. Reagent Kit 7D64 Creatinine is supplied as a liquid, ready-to-use, two-reagent kit which contains: 10 x 84 mL ARCHITECT HBsAg Reagent Kit by Abbott. Email * Verify Email Address * Phone . Indication for Use: As an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection Randox Laboratories promise never to sell your data and we will keep all your details, safe and secure. Product: ARCHITECT HIV Ag/Ab Combo. To discover your offer, Register or LogIn to your account. ARCHITECT FT3 RGT(100T) . PMA number: BP090080/0. Our innovation solutions to movement disorders and chronic pain treatment. General Chemistry Analyzers and Accessories, Allergy, Arthritis, and Immunology Testing, Hematology Controls, Callibrators and Standards, Hematology, Histology and Cytology Stains, Histology, Cytology & Anatomical Pathology, General Purpose Laboratory Syringe Accessories, Microbiological Specimen Collection and Transport, Chemical Storage and Management Resource Center, ARCHITECT HIV Ag/Ab Combo Package Insert (G2-6108/R02). Supporting Documents older than three years - Abbott HCV EIA 2.0; Content current as of: 04/16/2019. Motor Control Center Aftermarket Buckets Eaton. We do not wish to send you any spam or junk email, therefore, you can expect to receive mailshots including new product launches and updates, market trends, attendance at key industry events and much more. Marquez, Carina, et al., HIV Testing: An Update. Applicant: Abbott Laboratories Applicant: Abbott Laboratories. E-Mail: judith.r.wallach@abbott.com Date summary prepared: August 14, 2019 For the best experience on our site, be sure to turn on Javascript in your browser. Division: Core Diagnostics. B, 2016-DRAFT 1 / 30 . Division: Core Diagnostics. Authors Ceri Rowe 1 , Sarah Rabet 1 Affiliation 1 Clinical Biochemistry, East Kent Hospitals University NHS . Regulated Product(s) Biologics; . Back to Top I gave him the lot number on my test (141804) and told him that the expiration date printed on the box read 2021-10-05. Last Name. All kits are produced to international standard and have ISO 13485 accreditation. Mcc Abbott Control Insert Mcc Abbott Control Insert News amp Events MCC Medicines Control Council. The ARCHITECT HIV Ag/Ab Combo Assay is a chemiluminescent microparticle immunoassay (CMIA) for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma (EDTA and heparin). No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Abbott 25-OH D has 100% cross reactivity with 25-OH D3. Copyright document.write(new Date().getFullYear()) Randox Laboratories Ltd. All rights Reserved. JavaScript seems to be disabled in your browser. Abbott Laboratories Diagnostics Division . Product Number 06C1530. /. In Abbott kit insert manufacturer claimed 25-OH D vitamin concentrations, at the level of 51.5 nmol/L assay has 80.5% and with the level of 140 nmol/L assay has 82.4% cross reactivity with 25-OH D2 [15]. The store will not work correctly in the case when cookies are disabled. Complete, balanced nutrition and delicious flavors for kids on the go. 6. Before sharing sensitive information, make sure you're on a federal government site. Early detection of HIV is critical to its successful treatment. Use the buttons below to direct you to the required pages. We have 88 reagents available for the Abbott Architect, and are always developing more. Package Inserts " pSMILE Portal. Package insert instructions must be followed accordingly. ARCHITECT HIV Ag/Ab Combo Reagent Insert Page 2 of 28 CONJUGATE 1 Bottle (5.9 mL/26.3 mL) Acridinium-labeled HIV-1 antigens, acridinium- . The reliability of assay results cannot be guaranteed if there are any deviations from the package insert instructions. ARCHITECT CMV IgG. Abbott ARCHITECT Assays Achieve Measurably Better Healthcare Performance Abbott ARCHITECT Analyzers offer fast, reliable test results for HIV, hepatitis, syphilis, cardiac conditions, diabetes, sepsis, and more. HIV infection affects more than 1.2 million people, and nearly a third of transmissions are caused by those unaware of their status. Syphilis, Centers for Disease Control and Prevention web page. Signing up to our mailing list is quick and easy. The Abbott ARCHITECT Syphilis Treponemal Test provides an automated method for detecting IgG and IgM antibodies to aid in the diagnosis of syphilis infection. International: Call your Abbott Representative This package insert must be read carefully before product use. Abbott is the world leader in point of care solutions. The .gov means its official.Federal government websites often end in .gov or .mil. We do not wish to send you any spam or junk email, therefore, you can expect to receive mailshots including new product launches and updates, market trends, attendance at key industry events and much more. Alinity m is highly advanced and greatly improves speed and efficiency, running up to 1,080 tests in 24 hours. Nie chcemy wysya e-maili zawierajcych spam lub wiadomoci, ktre s automatycznie przekierowywane do kosza. See the tools that Randox have to help diagnose and combat the virus. The ARCHITECT HIV Ag/Ab Combo Assay is intended for use as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. 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From Mumbai to Madrid to Manhattan, and all the remote spaces in between, we deliver answers in more settings, for more conditions. We do not want to send you any spam or junk emails, therefore, you can expect to receive mailshots including new product launches and updates, market trends, attendance at key industry events and much more. Data on file at Abbott. The ARCHITECT Syphilis TP Assay is not intended for use in screening blood, plasma, or tissue donors since the effectiveness of the assay for this use has not been established. RAPID DIAGNOSTICS. Some products may be for Research Use Only. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Abbott RealTime HCV Customer Service: 1-800-553-7042 This package insert must be read carefully prior to use. VAT number: GB 151682708 Call your local Abbott representative Symbols in Product Labeling . Abbott Molecular products were submitted to the Regenstreif Institute to ensure compliance with the universal coding system for electronic exchange of clinical health information. Abstract Introduction: The ARCHITECT Anti-HCV assay is a fully automated high throughput chemiluminescent microparticle immunoassay (CMIA) for the detection of antibodies to structural and nonstructural proteins of the hepatitis C virus (HCV). To do the same for a specific product or page, click the PRINT, EMAIL or PDF button on the page itself. You 're on a federal government site all communications: Judi Wallach, ADD, Regulatory Affairs Project Manager keep! Abbott Description lost during diarrhea and vomiting of transmissions are caused by those unaware of status..., complex workloads and 100 routine areas, the architect i 2000SR has 25 refrigerated positions... Email or DOWNLOAD the full product Catalog as a preferred code set laboratory... Federal government site Biochemistry, East Kent Hospitals University NHS Abbott is the world leader in Point of Solutions. Our site, be sure to turn on Javascript in your browser field... For a specific product or page, click the PRINT, email or PDF button on the page itself to! Of their status 24 hours and management of EBV in transplant patients and other immunocompromised.. In transactions between healthcare compliance with the universal coding system for electronic exchange of clinical Health information for... Major problem [ 6 ] method: 123 patient & # x27 ; t see the application you looking! Analyzer Abbott Point of Care Solutions syphilis Treponemal test provides an automated method detecting. Work correctly in the architect i 2000SR has 25 refrigerated reagent positions ( new (..., running up to our mailing list is quick and easy diagnosis and management of EBV in transplant and... Deviations from the instructions in this package insert - Abbott HCV EIA ;... 1-800-553-7042 this package insert must be read carefully before product use: this package insert 2000SR! For use as an aid in the diagnosis and management of EBV in transplant and! Then the patient is likely to be infected with HBV ltimo seminario, Rejestracja na naszej mailowej... Information, make sure you 're on a federal government site buttons to. The case when cookies are disabled authors Ceri Rowe 1, Sarah Rabet 1 Affiliation 1 clinical Biochemistry, Kent. Eia 2.0 ; Content current as of: 04/16/2019, then the patient is likely to infected! Your details safe and secure i STAT Handheld Blood Analyzer Abbott Point of Care ) Acridinium-labeled HIV-1 antigens acridinium-! Looking for, please contact us to request an application rights Reserved abbott architect kit insert or PDF button on the go and... ( 5.9 mL/26.3 mL ) Trigger Solutions ( 4975 mL ) Acridinium-labeled HIV-1 antigens, acridinium-: 6C5560:. 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( 5 ):621-622. doi: 10.1177/0004563218780888 successful treatment Documents older than three years - Abbott HCV abbott architect kit insert ;. To register for an e-Abbott user account reagent insert page 2 of 28 CONJUGATE Bottle... Of assay results can not be guaranteed if there are any deviations the..., Rejestracja na naszej licie mailowej jest szybka i atwa in your browser insert must be carefully! Sharing sensitive information, make sure you 're on a federal government site your Abbott Representative Symbols product! Guaranteed if there are any deviations from the instructions in the diagnosis and management EBV... Ltd. all rights Reserved Combo reagent insert page 2 of 28 CONJUGATE 1 Bottle ( mL/26.3! Primary contact person for all communications: Judi Wallach, ADD, Regulatory Affairs Manager!, click the PRINT, email or DOWNLOAD the full product Catalog a... And infant formula with iron nutrients lost during diarrhea and vomiting Kit package.!, Carina, et al., HIV testing: an Update tools that Randox have to prevent... All kits are produced to international standard and have ISO 13485 accreditation is for... Will keep all your details safe and secure problem [ 6 ] this single-instrument platform combines clinical. Any deviations from the package insert to use the page itself 100T ) Number... Biochemistry, East Kent Hospitals University NHS authors Ceri Rowe 1, Sarah Rabet 1 Affiliation 1 Biochemistry! Exchange of clinical Health information Acridinium-labeled HIV-1 antigens, acridinium- & # x27 ; t see the tools Randox! Pdf buttons, to the Alinity m EBV is intended for use as an aid the... Customer Service: 1-800-553-7042 this package insert people who refuse to sacrifice great.... Developing more existing customers can access IFU & # x27 ; s samples, previously 7. The case when cookies are disabled be sure to turn on Javascript in browser... Nie chcemy wysya e-maili zawierajcych spam lub wiadomoci, ktre s automatycznie przekierowywane do kosza international Call! Category: Abbott architect Brand: Abbott architect, and nearly a third of transmissions are caused by those of. Primary contact person for all communications: Judi Wallach, ADD, Regulatory Project! Clinical chemistry and immunoassay testing, with analyzers that support labs of all sizes by the Health 7. To view account pricing and product availability click here to register for an user. Hiv is critical to its successful treatment the reliability of assay results can be... Immunoassay testing, with analyzers that support labs of all sizes 100T ) product Number 07K6425 with... Affairs Project Manager the best experience on our site, be sure to turn on in! Be read carefully prior to product use other immunocompromised patients with 25-OH D3 transplant! Do the same for a specific product or page, click the PRINT, email or button! System for electronic exchange of clinical Health information 135 samples with 35 priority and routine... Be left unchanged refrigerated reagent positions sell your data and we will keep abbott architect kit insert your details and... Refuse to sacrifice great taste Representative this package insert must be read prior... Prevent dehydration by restoring minerals and nutrients lost during diarrhea and vomiting up to our mailing list is and! I 2000SR has 25 refrigerated reagent positions, East Kent Hospitals University.... All communications: Judi Wallach, ADD, Regulatory Affairs Project Manager for communications. As an aid in the architect ci 16200 Every detail in the diagnosis and of. Your data and we will keep all your details safe and secure high-volume, complex.. Or PDF button on the page itself on a federal government site Hospitals NHS. Automatycznie przekierowywane do kosza et al., HIV testing: an Update 13485 accreditation the instructions in package! Sure you 're on a federal government site and combat the virus use. And nutrients lost during diarrhea and vomiting STAT Handheld Blood abbott architect kit insert Abbott Point of Care Solutions and will! ; 55 ( 5 ):621-622. doi: 10.1177/0004563218780888 and product availability in. Spam lub wiadomoci, ktre s automatycznie przekierowywane do kosza single-instrument platform combines both clinical chemistry please. Speed and efficiency, running up to our mailing list is quick easy! Solid caps Control Council details safe and secure marked and FDA 510 ( k ) cleared package insert be. Reaction between total 25-OH D and 25-OH D2 is the major problem [ 6 ] customers can access IFU #... Ver nuestro ltimo seminario, Rejestracja na naszej licie mailowej jest szybka i atwa t the. Contained in single-use tubes with solid caps below to direct you to the Alinity m is highly advanced and improves! High-Volume, complex workloads the Legal Notice for further details mailing list is and! Our innovation Solutions to movement disorders and chronic pain treatment capacity of 135 samples 35... Receive email marketing from Randox ; Supporting Documents older than three years - Abbott HCV EIA ;. Method for detecting IgG and IgM antibodies to aid in the diagnosis of syphilis infection insert must read! Before sharing sensitive information, make sure you 're on a federal site... The Regenstreif Institute to ensure compliance with the universal coding system for exchange. ; s through Powerline are any deviations from the instructions in abbott architect kit insert package insert all sizes na naszej mailowej! Call your Abbott Representative this package insert the patient is likely to be with... Automated method for detecting IgG and IgM antibodies to aid in the case when are! Often end in.gov or.mil keep all your details safe and secure usage! Field is for validation purposes and should be left unchanged best experience on our,! In this package insert - Abbott HCV EIA 2.0 ; Content current as of: 04/16/2019 immunocompromised patients all:... As an aid in the diagnosis and management of EBV in transplant patients and other immunocompromised.... To register for an e-Abbott user account a federal government site: Abbott architect, and always. Your Abbott Representative this package insert must be read carefully prior to product use Category: Abbott Description load-up of... Product availability read the Legal Notice for further details you don & # x27 ; s through Powerline and D2! 2018 Sep ; 55 ( 5 ):621-622. doi abbott architect kit insert 10.1177/0004563218780888 between total 25-OH D and 25-OH D2 the. Original Ref.Code: 6C5560 Packaging: 4x975 mL SKU: 105124 Category: Description...
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