510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
GQWClass II

Antigen, Cf, (Including Cf Control), Varicella-Zoster

21 CFR 866.3900 / Microbiology
FDA source (opens on fda.gov)

GQW is the FDA product code for Antigen, Cf, (Including Cf Control), Varicella-Zoster, a class II device type, regulated under 21 CFR 866.3900. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GQW
Device name
Antigen, Cf, (Including Cf Control), Varicella-Zoster
Regulation
21 CFR 866.3900
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
10
Ingested recalls
0

Clearances, product code GQW

By decision year
10 clearances under product code GQW with a decision year between 1980 and 2007, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GQW by decision year
YearClearances
19801
19852
19891
19901
19911
19941
19971
19991
20071

Applicants with the most clearances

Product code GQW
Applicants holding the most 510(k) clearances under product code GQW
ApplicantClearances
Viral Antigens, Inc.2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Bion Ent., Ltd.1
Ortho-Clinical Diagnostics, Inc.1
Institute Virion, Ltd.1
Light Diagnostics1
Orion Diagnostica, Inc.1
Viro Research LLC1
Zeus Scientific LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code