Product code GNW— Microbiology
IMAGEN RESPIRATORY SCREEN
- Classification name
- Antisera, Cf, Influenza Virus A, B, C
- Device class
- Class 1
- Regulation
- 21 CFR 866.3330
- Advisory panel
- Microbiology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code GNW
FDA has cleared devices under product code GNW between 1987 and 2009, filed by 8 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
- 2009
- 2008
- 2006
- 2002
- 2000
- 1998
- 1997
- 1996
- 1994
- 1991
- 1990
- 1987
Top applicants under product code GNW
Recent clearances under product code GNW
- K092882 — D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
- K092300 — MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
- K081746 — D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
- K061101 — D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
- K022713 — DFA RESPIRATORY VIRUS SCREENING & ID KIT
- K003204 — BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
- K974302 — LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
- K973954 — IMAGEN RESPIRATORY SCREEN
- K962037 — IMAGEN RESPIRATORY SCREEN
- K942172 — INFLUENZA A ANTIGEN TEST
- K942174 — INFLUENZA B ANITGEN TEST
- K913351 — INFLUENZA MAB TEST/INFLUENZA A TEST
- K913214 — INFLUENZA MAB TEST/INFLUENZA B TEST
- K896635 — VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY
- K872693 — INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN
- K872694 — YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN
Data sourced from openFDA. This site is unofficial and independent of the FDA.