FDA product code GRD: Antiserum, Hai, Mumps Virus
GRD is the FDA product code for antiserum, hai, mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GRD. The average 510(k) review took 123 days (median 123).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Hai, 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 GRD clearance
Top GRD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wellcome Diagnostics | 1 | 1984-01-10 |
Most recent GRD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833077 | Wellcome Diagnostics | WELLCOGEN H. INFLUENZAL ZL21 | 1984-01-10 | 123 |
Recalls for GRD devices
openFDA lists no recalls for product code GRD.
Frequently asked questions
What is FDA product code GRD?
GRD is the FDA product code for antiserum, hai, mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel.
What device class is GRD?
Class I, regulation 21 CFR 866.3380. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRD?
Across 1 cleared submissions the average was 123 days from receipt to decision (median 123).
Which companies have the most GRD clearances?
Wellcome Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GRD
- Run a recall and safety report across every GRD manufacturer
- Watch product code GRD 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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