FDA product code GMD: Antisera, Latex Agglutination, Cryptococcus Neoformans
GMD is the FDA product code for antisera, latex agglutination, cryptococcus neoformans. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel. FDA has cleared 10 510(k) submissions under GMD, from 6 different applicants. The average 510(k) review took 121 days (median 32). FDA has posted 3 recalls for GMD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Latex Agglutination, Cryptococcus Neoformans |
| Device class | Class II |
| Regulation | 21 CFR 866.3165 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GMD clearance
Top GMD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immuno-Mycologics, Inc. | 4 | 2012-03-28 |
| Meridian Diagnostics, Inc. | 2 | 1989-09-08 |
| Trinity Laboratories, Inc. | 1 | 1994-02-17 |
| Alexon Biomedical, Inc. | 1 | 1993-11-22 |
| American Scientific Products | 1 | 1981-08-31 |
1 more applicants have GMD clearances. See the full list in Caduvo.
Most recent GMD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K112422 | Immuno-Mycologics, Inc. | CRAG LATERAL FLOW ASSAY (LFA) | 2012-03-28 | 218 |
| K102286 | Immuno-Mycologics, Inc. | CRAG LATERAL FLOW ASSAY (CRAG LFA) | 2011-07-20 | 342 |
| K930418 | Trinity Laboratories, Inc. | CRYPTO-LEX SYSTEM | 1994-02-17 | 387 |
| K933997 | Alexon Biomedical, Inc. | PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY | 1993-11-22 | 97 |
| K894845 | Meridian Diagnostics, Inc. | (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE | 1989-09-08 | 28 |
Recalls for GMD devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-01-03.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code GMD?
GMD is the FDA product code for antisera, latex agglutination, cryptococcus neoformans. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel.
What device class is GMD?
Class II, regulation 21 CFR 866.3165. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GMD?
Across 10 cleared submissions the average was 121 days from receipt to decision (median 32).
Which companies have the most GMD clearances?
Immuno-Mycologics, Inc. (4); Meridian Diagnostics, Inc. (2); Trinity Laboratories, Inc. (1); Alexon Biomedical, Inc. (1); American Scientific Products (1).
Have GMD devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2022-01-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GMD
- Run a recall and safety report across every GMD manufacturer
- Watch product code GMD 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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