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

Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4

21 CFR 866.3400 / Microbiology
FDA source (opens on fda.gov)

GQS is the FDA product code for Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4, a class I device type, regulated under 21 CFR 866.3400. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GQS
Device name
Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
Regulation
21 CFR 866.3400
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
11
Ingested recalls
0

Clearances, product code GQS

By decision year
11 clearances under product code GQS with a decision year between 1980 and 2009, 1987 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GQS by decision year
YearClearances
19801
19852
19873
19882
19911
19951
20091

Applicants with the most clearances

Product code GQS
Applicants holding the most 510(k) clearances under product code GQS
ApplicantClearances
Microscan Div. Baxter Healthcare Corp.3
Baxter Diagnostics, Inc.2
Institute Virion, Ltd.2
Dako Diagnostics, Ltd.1
Ortho-Clinical Diagnostics, Inc.1
Orion Diagnostica, Inc.1
Virion (U.S.), Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code