Panels › Microbiology › Product code GNX · Class 1
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Regulation 866.3330
0510(k)s in 12 months (18 all time)
0recalls in 12 months (10 all time)
7recalls that name a 510(k)
Top companies in GNX
| Company | 510(k)s | Recalls |
|---|---|---|
| Binax, Inc. dba IMPD | 0 | 4 |
| Quidel Corp. | 3 | 1 |
| Princeton Biomeditech Corp | 0 | 3 |
| Institute Virion , Ltd. | 2 | 0 |
| Microscan Div. Baxter Healthcare Corp. | 2 | 0 |
| Remel, Inc. | 1 | 1 |
| Whittaker Bioproducts, Inc. | 2 | 0 |
| Alere Scarborough, Inc D/B/A Binax, Inc. | 1 | 0 |
| Baxter Diagnostics, Inc. | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2013 | Remel Inc Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pou Terminated |
GNX | None listed |
| Feb 14, 2013 | Quidel Corporation Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. Terminated |
GNX | K112177 |
| Aug 31, 2012 | Princeton Biomeditech Corp Status Flu A + B Test
Manufactured by
Princeton Bio Meditech Corporation
Monmouth Junction, NJ 08852 USA.
The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type Terminated |
GNX | K083746 |
| Aug 31, 2012 | Princeton Biomeditech Corp 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 Terminated |
GNX | K083746 |
| Aug 31, 2012 | Princeton Biomeditech Corp Orasure QuickFlu Rapid A+B Test
Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA.
The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and Terminated |
GNX | K083746 |
| Nov 3, 2008 | Inverness Medical BioStar Inc. BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027 Terminated |
GNX | K023556 |
| May 23, 2007 | Binax, Inc. dba IMPD BinaxNOW A&B Kit 10 Test Kit (Japan)
Part No. 416-110J contains NP Swabs with '8995' labeled on the swab wrapper Terminated |
GNX | None listed |
| May 23, 2007 | Binax, Inc. dba IMPD BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065, contain NP Swabs with '8995' labeled on the swab wrapper Terminated |
GNX | None listed |
| May 23, 2007 | Binax, Inc. dba IMPD BinaxNOW Influenza A&B 22 Test Kit
Part Number: 416-022, contains NP Swabs with '8995' labeled on the swab wrapper Terminated |
GNX | K062109 |
| May 23, 2007 | Binax, Inc. dba IMPD BinaxNOW Influenza A&B 10 Test KIT
Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper Terminated |
GNX | K062109 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.