FDA product code GRJ: Antigen, Cf, (Including Cf Control), Rubeola
GRJ is the FDA product code for antigen, cf, (including cf control), rubeola. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GRJ, from 2 different applicants. The average 510(k) review took 208 days (median 208).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf, (Including Cf Control), Rubeola |
| Device class | Class I |
| Regulation | 21 CFR 866.3520 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GRJ clearance
Top GRJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Institute Virion , Ltd. | 1 | 1985-09-26 |
| Orion Diagnostica, Inc. | 1 | 1980-12-31 |
Most recent GRJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843662 | Institute Virion , Ltd. | MEASLES VIRUS RUBEOLA | 1985-09-26 | 374 |
| K802932 | Orion Diagnostica, Inc. | MEASLES VIRUS & CONTROLS | 1980-12-31 | 42 |
Recalls for GRJ devices
openFDA lists no recalls for product code GRJ.
Frequently asked questions
What is FDA product code GRJ?
GRJ is the FDA product code for antigen, cf, (including cf control), rubeola. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel.
What device class is GRJ?
Class I, regulation 21 CFR 866.3520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRJ?
Across 2 cleared submissions the average was 208 days from receipt to decision (median 208).
Which companies have the most GRJ clearances?
Institute Virion , Ltd. (1); Orion Diagnostica, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GRJ
- Run a recall and safety report across every GRJ manufacturer
- Watch product code GRJ 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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