FDA product code GRB: Antiserum, Cf, Mumps Virus
GRB is the FDA product code for antiserum, cf, mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GRB, from 2 different applicants. The average 510(k) review took 81 days (median 81).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Cf, 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 GRB clearance
Top GRB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Whittaker Bioproducts, Inc. | 1 | 1987-10-06 |
| Sita, Inc. | 1 | 1987-09-18 |
Most recent GRB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872733 | Whittaker Bioproducts, Inc. | FIAX TEST KIT FOR MUMPS-G ANTIBODIES | 1987-10-06 | 89 |
| K872699 | Sita, Inc. | MUMPS CF ANTIGEN AND CONTROL ANTIGEN | 1987-09-18 | 73 |
Recalls for GRB devices
openFDA lists no recalls for product code GRB.
Frequently asked questions
What is FDA product code GRB?
GRB is the FDA product code for antiserum, cf, mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel.
What device class is GRB?
Class I, regulation 21 CFR 866.3380. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRB?
Across 2 cleared submissions the average was 81 days from receipt to decision (median 81).
Which companies have the most GRB clearances?
Whittaker Bioproducts, Inc. (1); Sita, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GRB
- Run a recall and safety report across every GRB manufacturer
- Watch product code GRB 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times