FDA product code GRE: Antiserum, Fluorescent, Rubeola
GRE is the FDA product code for antiserum, fluorescent, rubeola. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under GRE, from 4 different applicants. The average 510(k) review took 80 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Fluorescent, 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 GRE clearance
Top GRE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gull Laboratories, Inc. | 1 | 1988-12-05 |
| Idt, A Division of Whittaker M.A. Bioproducts | 1 | 1985-10-22 |
| Electro-Nucleonics Laboratories, Inc. | 1 | 1982-07-30 |
| Microbiological Assoc. | 1 | 1977-06-14 |
Most recent GRE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884004 | Gull Laboratories, Inc. | RUBEOLA TEST | 1988-12-05 | 75 |
| K853067 | Idt, A Division of Whittaker M.A. Bioproducts | FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT | 1985-10-22 | 92 |
| K821249 | Electro-Nucleonics Laboratories, Inc. | ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS | 1982-07-30 | 91 |
| K770687 | Microbiological Assoc. | MEASLESVIRUS FLOURE. CONJUGATED ANTISERU | 1977-06-14 | 62 |
Recalls for GRE devices
openFDA lists no recalls for product code GRE.
Frequently asked questions
What is FDA product code GRE?
GRE is the FDA product code for antiserum, fluorescent, rubeola. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel.
What device class is GRE?
Class I, regulation 21 CFR 866.3520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRE?
Across 4 cleared submissions the average was 80 days from receipt to decision (median 83).
Which companies have the most GRE clearances?
Gull Laboratories, Inc. (1); Idt, A Division of Whittaker M.A. Bioproducts (1); Electro-Nucleonics Laboratories, Inc. (1); Microbiological Assoc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GRE
- Run a recall and safety report across every GRE manufacturer
- Watch product code GRE 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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