FDA product code GQS: Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
GQS is the FDA product code for antigens, cf (including cf control), parainfluenza virus 1-4. It is a Class I device, regulated under 21 CFR 866.3400 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under GQS, from 7 different applicants. The average 510(k) review took 135 days (median 91).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 |
| Device class | Class I |
| Regulation | 21 CFR 866.3400 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GQS clearance
Top GQS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microscan Div. Baxter Healthcare Corp. | 3 | 1987-06-26 |
| Baxter Diagnostics, Inc. | 2 | 1988-11-22 |
| Institute Virion , Ltd. | 2 | 1985-09-26 |
| Diagnostic Hybrids, Inc. | 1 | 2009-12-23 |
| Dako Diagnostics , Ltd. | 1 | 1995-01-09 |
2 more applicants have GQS clearances. See the full list in Caduvo.
Most recent GQS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093415 | Diagnostic Hybrids, Inc. | D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT | 2009-12-23 | 51 |
| K943557 | Dako Diagnostics , Ltd. | IMAGEN | 1995-01-09 | 171 |
| K905385 | Virion (U.S.), Inc. | P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN | 1991-03-21 | 111 |
| K884194 | Baxter Diagnostics, Inc. | PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT | 1988-11-22 | 47 |
| K884193 | Baxter Diagnostics, Inc. | PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT | 1988-11-22 | 47 |
Recalls for GQS devices
openFDA lists no recalls for product code GQS.
Frequently asked questions
What is FDA product code GQS?
GQS is the FDA product code for antigens, cf (including cf control), parainfluenza virus 1-4. It is a Class I device, regulated under 21 CFR 866.3400 and reviewed by the Microbiology panel.
What device class is GQS?
Class I, regulation 21 CFR 866.3400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GQS?
Across 11 cleared submissions the average was 135 days from receipt to decision (median 91).
Which companies have the most GQS clearances?
Microscan Div. Baxter Healthcare Corp. (3); Baxter Diagnostics, Inc. (2); Institute Virion , Ltd. (2); Diagnostic Hybrids, Inc. (1); Dako Diagnostics , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GQS
- Run a recall and safety report across every GQS manufacturer
- Watch product code GQS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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