510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GNXClass I

Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

21 CFR 866.3330 / Microbiology
FDA source (opens on fda.gov)

GNX is the FDA product code for Antigens, Cf (Including Cf Control), Influenza Virus A, B, C, a class I device type, regulated under 21 CFR 866.3330. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
GNX
Device name
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Regulation
21 CFR 866.3330
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
18
Ingested recalls
10

Clearances, product code GNX

By decision year
18 clearances under product code GNX with a decision year between 1981 and 2013, 2013 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code GNX by decision year
YearClearances
19811
19852
19872
19882
19902
19921
19971
20121
20136

Applicants with the most clearances

Product code GNX
Applicants holding the most 510(k) clearances under product code GNX
ApplicantClearances
Ortho-Clinical Diagnostics, Inc.3
Institute Virion, Ltd.2
Microscan Div. Baxter Healthcare Corp.2
Whittaker Bioproducts, Inc.2
Alere Scarborough, Inc D/B/A Binax, Inc.1
Baxter Diagnostics, Inc.1
Baxter Healthcare Corporation1
Boots-Celltech Diagnostics, Inc.1
Orion Diagnostica, Inc.1
Remel Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code