FDA product code GQH: Antigen, Cf (Including Cf Control), Cytomegalovirus
GQH is the FDA product code for antigen, cf (including cf control), cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel. FDA has cleared 19 510(k) submissions under GQH, from 18 different applicants. The average 510(k) review took 117 days (median 92). FDA has posted 1 recall for GQH devices.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf (Including Cf Control), Cytomegalovirus |
| Device class | Class II |
| Regulation | 21 CFR 866.3175 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GQH clearance
Top GQH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Litton Bionetics | 2 | 1980-09-16 |
| Intracel Corp. | 1 | 1998-12-14 |
| Viral Antigens, Inc. | 1 | 1997-03-18 |
| Light Diagnostics | 1 | 1994-05-05 |
| Stellar Bio Systems, Inc. | 1 | 1988-12-05 |
13 more applicants have GQH clearances. See the full list in Caduvo.
Most recent GQH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K982311 | Intracel Corp. | BARTELS CINAKIT CMV ANTIGENEMIA | 1998-12-14 | 166 |
| K964875 | Viral Antigens, Inc. | CMV ANTIGEN CONTROL SLIDES | 1997-03-18 | 103 |
| K935809 | Light Diagnostics | CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY | 1994-05-05 | 154 |
| K882835 | Stellar Bio Systems, Inc. | INDIRECT FLUORESCENT ASSAY FOR (HCMV) | 1988-12-05 | 150 |
| K882024 | Whittaker Bioproducts, Inc. | FITC MURINE MONOCLONAL ANTI-CMV IGG | 1988-08-03 | 78 |
Recalls for GQH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-01-23.
Frequently asked questions
What is FDA product code GQH?
GQH is the FDA product code for antigen, cf (including cf control), cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel.
What device class is GQH?
Class II, regulation 21 CFR 866.3175. Typical premarket route: 510(k).
How long does a 510(k) take for product code GQH?
Across 19 cleared submissions the average was 117 days from receipt to decision (median 92).
Which companies have the most GQH clearances?
Litton Bionetics (2); Intracel Corp. (1); Viral Antigens, Inc. (1); Light Diagnostics (1); Stellar Bio Systems, Inc. (1).
Have GQH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-01-23.
Next steps
- Run an FDA pathway report with predicate devices for product code GQH
- Run a recall and safety report across every GQH manufacturer
- Watch product code GQH 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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