WebJun 10, 2024 · Device Identifier (DI) Information Brand Name: BinaxNOW COVID-19 Ag Card Home Test Version or Model: 195-100 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: Alere Scarborough, Inc. Primary DI Number: 00811877011330 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 WebJun 10, 2024 · AccessGUDID - BinaxNOW COVID-19 Antigen Self Test (00811877011408)- A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. ... Version or Model: 195-160 Commercial Distribution Status: In Commercial Distribution Catalog Number: ... Lot or Batch Number: Yes Serial Number: …
BinaxNOW COVID-19 Antigen Self Test - AbbottStore
WebJun 23, 2024 · Search FDA . Home; Food; Drugs; Medical Devices; Radiation-Emitting Products; Vaccines, Blood & Biologics ... Tobacco Products . MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW¿ COVID-19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. FDA … WebBinaxNOW™ Professional Use: Manufacturer: Abbott Rapid Dx North America LLC: Country of Origin: United States: Application: Rapid Test Kit: Contents 1 (40) Test Cards, 7.5 mL Extraction Reagent, (40) Sterile Nasal Swabs, Positive Control Swab, Negative Control Swab, Product Insert, Procedure Card: Number of Tests: 40 Tests: Product Dating polyspin exports limited
COVID-19 Antigen Testing Diagnostics Testing Newsroom - Abbott
WebThis test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior … WebNov 5, 2024 · Use the instructions to see the letter and listing of BinaxNOW™ COVID-19 Ag Card lots which qualify for this expiry extension. Please pay close attention to the lot … WebJan 15, 2024 · The U.S. Food and Drug Administration has increased the shelf life for one of the most popular at-home COVID-19 test kits. The agency announced that Abbott's BinaxNow COVID-19 Ag Card Home Test is now approved for a 15-month expiration window. This follows a request by the company to provide a longer shelf life for its test, … poly spin string tension maintenance