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. These assays showed good agreement with the ACS: 180 with a little more scatter about the correlation line in the . We have solutions available for laboratory testing and consumer/company testing. 5.0. . Reagent Kit 7D64 Creatinine is supplied as a liquid, ready-to-use, two-reagent kit which contains: 10 x 84 mL The ARCHITECT Syphilis TP Assay is intended to be used as an initial diagnostic test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. To do the same for a specific product or page, click the PRINT, EMAIL or PDF button on the page itself. Data on file at Abbott. Last Name. Read more in our Privacy Policy. 4.2. The Abbott ARCHITECT Syphilis Treponemal Test provides an automated method for detecting IgG and IgM antibodies to aid in the diagnosis of syphilis infection. Before sharing sensitive information, make sure you're on a federal government site. 2021 Abbott. Key to symbols used Reference Number Calibrator A . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. All kits are produced to international standard and have ISO 13485 accreditation. Nutrition for busy people who refuse to sacrifice great taste. Marquez, Carina, et al., HIV Testing: An Update. Our POC diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, & toxicology. Telephone Number: (224) 667-1132 . 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For in vitro diagnostic use only. Nutritionally complete, amino acid-based medical food and infant formula with iron. International: Call your Abbott Representative This package insert must be read carefully before product use. 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. Syphilis, Centers for Disease Control and Prevention web page. Carefully follow the package insert instructions. The assay may also be used to assist in the diagnosis of HIV-1/HIV-2 infection in pregnant woman and pediatric patients (i.e., children as young as two years of age). ARCHITECT TSH RGT(2000T) Product Number 07K6230. Division: Core Diagnostics. Signing up to our mailing list is quick and easy. Please sign in to view account pricing and product availability. Package Inserts " pSMILE Portal. Abbott Park, IL 60064 . Regulated Product(s) Biologics; For the best experience on our site, be sure to turn on Javascript in your browser. ARCHITECT ci 16200 Every detail in the ARCHITECT ci 16200 has been designed to handle high-volume, complex workloads. However, this assay can be used for blood donor screening in urgent situations where the use of traditional licensed blood donor screening tests are impractical or unavailable. This package insert contains information to run the Creatinine assay on the ARCHITECT c Systems and the AEROSET System. Carefully follow the package insert instructions. Currently we use the Abbott Architect Total PSA assay. Applicant: Abbott Laboratories Cross reaction between total 25-OH D and 25-OH D2 is the major problem [6]. Add to Cart. Method: 123 patient's samples, previously . Signing up to our mailing list is quick and easy. 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. Approval Date:6/18/2010, An official website of the United States government, : Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. 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). 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. 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. Randox Laboratories promise never to sell your data and we will keep all your details, safe and secure. For more information on product application and availability, please contact your local Randox Representative. Potential interference in the Abbott Architect 2nd generation total testosterone assay Ann Clin Biochem. [table "419" not found /] Epub 2018 Jun 6. Please contact your local distributor. Read PI05APR2006 LTR doc. LOINC Code Information. 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. The assay may also be used to assist in the diagnosis of HIV-1/HIV-2 infection in pregnant woman and pediatric patients (i.e., children as young as two years of age). First Name. 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). This assay is a two-step Chemiluminescent Microparticle Immunoassay (CMIA) used for the . To share the full Product Catalog, please use the PRODUCT CATALOG > DOWNLOAD option from the navigation bar at the top of the page. NOTE: Changes Highlighted . 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. The .gov means its official.Federal government websites often end in .gov or .mil. Package insert instructions must be followed accordingly. Our innovation solutions to movement disorders and chronic pain treatment. I would like to receive emails with new product releases and updates from Randox Laboratories, market trends, and more. The ARCHITECT HIV Ag/Ab Combo Reagent Kit must . Existing customers can access IFU's through Powerline. 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. All Rights Reserved. If you don't see the application you are looking for, please contact us to request an application. Add to Cart. 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 % 10697136_EN Rev. ARCHITECT FERRITIN RGT(100T) Product Number 07K5925. 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. PMA number:BP090080/0 We have 88 reagents available for the Abbott Architect, and are always developing more. RealTime HIV 1 Viral Load Assay Abbott Molecular. Some products may be for Research Use Only. Read more in our. Package insert instructions must be followed accordingly. PDF ARCHITECT BHCG RGT (100T) Product Number 07K7825 ARC TOTAL BHCG RGT 100 TEST Qty Unit: Each Add to Cart Remove caps from the tube prior to use. ARCHITECT Operations Manual 96211-116. 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. For the best experience on our site, be sure to turn on Javascript in your browser. Randox Laboratories promises never to sell your data and we will keep all your details, safe and secure. Product Number 06C1530. Clinical Chemistry AVAILABLE IN 3 MODEL SIZES TO HANDLE DIFFERENT LABORATORY TEST VOLUMES These instruments provide the high-quality, consistent STAT results and ease of use your laboratory demands from its instruments. This field is for validation purposes and should be left unchanged. The reliability of assay results cannot be guaranteed if there are any deviations from the package insert instructions. The store will not work correctly in the case when cookies are disabled. 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. The Abbott ARCHITECT Syphilis Treponemal Test provides an automated method for detecting IgG and IgM antibodies to aid in the diagnosis of syphilis infection. Division: Core Diagnostics. Supporting Documents older than three years - Abbott HCV EIA 2.0; Content current as of: 04/16/2019. Existing customers can access IFUs through Powerline. Abbott 25-OH D has 100% cross reactivity with 25-OH D3. Randox Laboratories are providing the tools required to combat and detect COVID-19. 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). 100 Abbott Park Road . 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. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. I do not want to receive email marketing from Randox. Fax Number: (224) 667-4836 . RAPID DIAGNOSTICS. 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.
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