FDA product code GRA: Antiserum, Fluorescent, Mumps Virus
GRA is the FDA product code for antiserum, fluorescent, 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 GRA, from 3 different applicants. The average 510(k) review took 63 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Fluorescent, 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 GRA clearance
Top GRA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bion Ent., Ltd. | 1 | 1989-10-16 |
| Electro-Nucleonics Laboratories, Inc. | 1 | 1982-12-03 |
| Flow Laboratories, Inc. | 1 | 1977-03-01 |
Most recent GRA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894624 | Bion Ent., Ltd. | MUMPS VIRUS | 1989-10-16 | 88 |
| K822826 | Electro-Nucleonics Laboratories, Inc. | ANTIBODY TO MUMPS VIRUS IFA TEST | 1982-12-03 | 73 |
| K770216 | Flow Laboratories, Inc. | VIRAL ANTISERA, FLUORESCEIN LABELED | 1977-03-01 | 27 |
Recalls for GRA devices
openFDA lists no recalls for product code GRA.
Frequently asked questions
What is FDA product code GRA?
GRA is the FDA product code for antiserum, fluorescent, mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel.
What device class is GRA?
Class I, regulation 21 CFR 866.3380. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRA?
Across 3 cleared submissions the average was 63 days from receipt to decision (median 73).
Which companies have the most GRA clearances?
Bion Ent., Ltd. (1); Electro-Nucleonics Laboratories, Inc. (1); Flow Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GRA
- Run a recall and safety report across every GRA manufacturer
- Watch product code GRA 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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