FDA product code GRC: Antigen, Cf (Including Cf Control), Mumps Virus
GRC is the FDA product code for antigen, cf (including cf control), mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under GRC, from 3 different applicants. The average 510(k) review took 122 days (median 124).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf (Including Cf Control), Mumps Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3380 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GRC clearance
Top GRC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Virion (U.S.), Inc. | 1 | 1991-06-17 |
| Hazleton Dutchland, Inc. | 1 | 1983-12-27 |
| Orion Diagnostica, Inc. | 1 | 1980-12-31 |
Most recent GRC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K905306 | Virion (U.S.), Inc. | MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN | 1991-06-17 | 201 |
| K832873 | Hazleton Dutchland, Inc. | MUMPS COMPLEMENT FIXATION & HEMAGGLU | 1983-12-27 | 124 |
| K802933 | Orion Diagnostica, Inc. | MUMPS S & V ANTIGENS & CONTROLS | 1980-12-31 | 42 |
Recalls for GRC devices
openFDA lists no recalls for product code GRC.
Frequently asked questions
What is FDA product code GRC?
GRC is the FDA product code for antigen, cf (including cf control), mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel.
What device class is GRC?
Class I, regulation 21 CFR 866.3380. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRC?
Across 3 cleared submissions the average was 122 days from receipt to decision (median 124).
Which companies have the most GRC clearances?
Virion (U.S.), Inc. (1); Hazleton Dutchland, Inc. (1); Orion Diagnostica, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GRC
- Run a recall and safety report across every GRC manufacturer
- Watch product code GRC 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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