Product code GNX— Microbiology
ALERE BINAXNOW INFLUENZA A & B CARD
- Classification name
- Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
- Device class
- Class 1
- Regulation
- 21 CFR 866.3330
- Advisory panel
- Microbiology
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code GNX
FDA has cleared devices under product code GNX between 1981 and 2013, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2013
- 2012
- 1997
- 1992
- 1990
- 1988
- 1987
- 1985
- 1981
Top applicants under product code GNX
Recent clearances under product code GNX
- K133411 — ALERE BINAXNOW INFLUENZA A & B CARD
- K132352 — SAS FLUALERT A & B, SAS INFLUENZA A TEST
- K131804 — REMEL XPECT FLU A&B
- K131599 — QUICK VUE INFLUENZA
- K131606 — SOFIA INFLUENZA A+B FIA
- K131619 — QUICKVUE INFLUENZA A+B
- K123182 — OSOM INFLUENZA A&B TEST MODEL 190
- K971494 — VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
- K924006 — BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY
- K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B
- K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A
- K884191 — INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION
- K872958 — IMAGEN INFLUENZA VIRUS A AND B TESTMI
- K871231 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B
- K871233 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A
- K843659 — INFLUENZA A2 VIRUS
- K843660 — IN FLUENZA B VIRUS
- K802931 — INFLUENZA A & B S-ANTIGEN & CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.