Ag Card COVID-19 Rapid POC Test
Abbott BinaxNow Ag Card Rapid Antigen Test is a rapid qualitative point of care test that detects SARS-CoV-2 directly from nasal swab specimens within 15 mins.
| Country of Origin | United States |
| Application | Rapid Test Kit |
| Contents | (40) Test cards, Patient Collection Nasal Swabs, Positive Control Swab, Blank Nasal Swab for Negative Control, Product Insert, Procedure Card Healthcare Provider & Patient COVID-19 Fact Sheets |
| Storage | USP Controlled Room Temperature |
| Test Format | Test Device |
| Test Method | Lateral Flow Immunochromatographic Assay |
| Part No. | 195-000 |
| Test Type | Rapid Antigen Detection |
| Time to Results | 15 Minute Results |
| Box Packing | 40 Tests |
| Case Packing | 16 Kits (640 Tests) |
| Application | Rapid Antigen Test |
| Pallet Packing | 10 Cases (6,400 Tests) |
Abbott BinaxNOW Antigen Tests
- BinaxNOW Antigen Test has been granted emergency use authorization (EUA) by the FDA for use at the point-of-care setting: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- During the duration of the emergency, this test can be performed in a patient care setting that is operating under a CLIA Waiver, Certificate of Compliance, or Certificate of Accreditation
- Results are for the identification of nucleocapsid antigens of SARS-CoV-2
- The BinaxNOW™ Ag Card COVID-19 test is intended for use by medical professionals and laboratory personnel trained to perform the test
- Anterior (nare) nasal swab for superior specimen collection and patient comfort
- Each kit contains 40 test cards, nasal swabs, positive control swab, blank nasal swab for negative control, product insert, procedure card, and healthcare provider and patient COVID-19 fact sheets.
Abbott BinaxNow POC Rapid Antigen Covid Test Deck – LILOclean
EUA – BinaxNOW™ COVID-19 Ag Card
Abbott-BinaxNOW-Patient Fact Sheet
Abbott-BinaxNOW-HCP Fact Sheet
BinaxNOW™ COVID-19 Ag Card SDS
BinaxNOW™ COVID-19 Ag Card Clinical and Laboratory Standards Institute (CLSI) Document
Introduction to CLIA-Waived Testing Document
BinaxNOW™ COVID-19 Ag Card Product Insert
BinaxNOW™ COVID-19 Ag Card Procedure Card
NAVICA Administrator Quick Reference Guide
Variants Study – Abbott BinaxNOW™
