Home / Device Classification / GNW

GNW — Antisera, Cf, Influenza Virus A, B, C Class I

FDA Device Classification

FDA product code GNW covers "Antisera, Cf, Influenza Virus A, B, C", a Class I medical device regulated under 21 CFR 866.3330. Submissions are reviewed by the Microbiology panel. At least 16 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GNW
Device Class
Class I
Regulation Number
866.3330
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K092882diagnostic hybridsD3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KITOctober 21, 2009
K092300diagnostic hybridsMODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITAugust 28, 2009
K081746diagnostic hybridsD3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KITDecember 23, 2008
K061101diagnostic hybridsD3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITNovember 20, 2006
K022713diagnostic hybridsDFA RESPIRATORY VIRUS SCREENING & ID KITDecember 18, 2002
K003204intracelBARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KITNovember 7, 2000
K974302light diagnosticsLIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BApril 8, 1998
K973954dako diagnosticsIMAGEN RESPIRATORY SCREENDecember 22, 1997
K962037dako diagnosticsIMAGEN RESPIRATORY SCREENDecember 26, 1996
K942172neogenexINFLUENZA A ANTIGEN TESTJuly 6, 1994
K942174neogenexINFLUENZA B ANITGEN TESTJune 30, 1994
K913351gull laboratoriesINFLUENZA MAB TEST/INFLUENZA A TESTDecember 17, 1991
K913214gull laboratoriesINFLUENZA MAB TEST/INFLUENZA B TESTDecember 13, 1991
K896635baxter healthcareVIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODYFebruary 2, 1990
K872694sitaYNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGENSeptember 18, 1987
K872693sitaINFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGENSeptember 18, 1987

FDA data resources