Device product
Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Z-2307-2012
Product summary
- Event
- Event 62537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 103 kits (22 tests per kit)
- Official record key
device-enforcement:Z-2307-2012
Official wording
Reason: There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Code information: 510 k K083746 Catalog Number FLU22 Lot numbers 441A11, 441C11
Distribution pattern: Nationwide Distribution-including the states of NJ, NY, and PA.
Derived failure modes
-
Unknown
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.