FDA product code GMP: Antisera, Control For Nontreponemal Tests
GMP is the FDA product code for antisera, control for nontreponemal tests. It is a Class II device, regulated under 21 CFR 866.3820 and reviewed by the Microbiology panel. FDA has cleared 9 510(k) submissions under GMP, from 9 different applicants. The average 510(k) review took 90 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Control For Nontreponemal Tests |
| Device class | Class II |
| Regulation | 21 CFR 866.3820 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GMP clearance
Top GMP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ampcor Diagnostics, Inc. | 1 | 1998-07-06 |
| Consolidated Technologies, Inc. | 1 | 1996-08-08 |
| Remel, L.P. | 1 | 1996-07-30 |
| Allelix Diagnostics, Inc. | 1 | 1989-03-15 |
| Texas Immunology, Inc. | 1 | 1988-02-04 |
4 more applicants have GMP clearances. See the full list in Caduvo.
Most recent GMP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K980638 | Ampcor Diagnostics, Inc. | ADI SYPHILIS RPR LIQUID CONTROLS | 1998-07-06 | 137 |
| K961998 | Consolidated Technologies, Inc. | QUALITROL SYPHSERO CONTROL SET | 1996-08-08 | 78 |
| K955143 | Remel, L.P. | RPR LIQUID CONTROLS | 1996-07-30 | 260 |
| K885298 | Allelix Diagnostics, Inc. | VISUWELL REAGIN TEST 960 TEST KIT | 1989-03-15 | 78 |
| K875180 | Texas Immunology, Inc. | V-TREND RPRL CARD TEST | 1988-02-04 | 49 |
Recalls for GMP devices
openFDA lists no recalls for product code GMP.
Frequently asked questions
What is FDA product code GMP?
GMP is the FDA product code for antisera, control for nontreponemal tests. It is a Class II device, regulated under 21 CFR 866.3820 and reviewed by the Microbiology panel.
What device class is GMP?
Class II, regulation 21 CFR 866.3820. Typical premarket route: 510(k).
How long does a 510(k) take for product code GMP?
Across 9 cleared submissions the average was 90 days from receipt to decision (median 78).
Which companies have the most GMP clearances?
Ampcor Diagnostics, Inc. (1); Consolidated Technologies, Inc. (1); Remel, L.P. (1); Allelix Diagnostics, Inc. (1); Texas Immunology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GMP
- Run a recall and safety report across every GMP manufacturer
- Watch product code GMP 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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