FDA product code GMI: Antigen, Cf And / Or Id, Coccidioides Immitis
GMI is the FDA product code for antigen, cf and / or id, coccidioides immitis. It is a Class II device, regulated under 21 CFR 866.3135 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under GMI, from 6 different applicants. The average 510(k) review took 67 days (median 28). FDA has posted 1 recall for GMI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf And / Or Id, Coccidioides Immitis |
| Device class | Class II |
| Regulation | 21 CFR 866.3135 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GMI clearance
Top GMI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 4 | 1980-01-24 |
| American Scientific Products | 2 | 1981-08-31 |
| Immuno-Mycologics, Inc. | 2 | 1979-08-16 |
| Schiff & Co. | 1 | 1989-10-31 |
| Nolan Biological Laboratories, Inc. | 1 | 1980-09-26 |
1 more applicants have GMI clearances. See the full list in Caduvo.
Most recent GMI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894617 | Schiff & Co. | OLYMPUS PK-TP SYSTEM REACTIVE CONTROL | 1989-10-31 | 103 |
| K812190 | American Scientific Products | COCCIDIOIDES IMMUNODIFFUSION SYSTEM | 1981-08-31 | 28 |
| K812185 | American Scientific Products | FUNGAL IMMUNODIFFUSION SYSTEM | 1981-08-25 | 22 |
| K802129 | Nolan Biological Laboratories, Inc. | IMMUNODIFFUSION REAGENTS/SEROLOGICAL | 1980-09-26 | 53 |
| K792716 | Meridian Diagnostics, Inc. | CANDIDA ALBICANS, ANTIGEN | 1980-01-24 | 28 |
Recalls for GMI devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-02-10.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code GMI?
GMI is the FDA product code for antigen, cf and / or id, coccidioides immitis. It is a Class II device, regulated under 21 CFR 866.3135 and reviewed by the Microbiology panel.
What device class is GMI?
Class II, regulation 21 CFR 866.3135. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GMI?
Across 11 cleared submissions the average was 67 days from receipt to decision (median 28).
Which companies have the most GMI clearances?
Meridian Diagnostics, Inc. (4); American Scientific Products (2); Immuno-Mycologics, Inc. (2); Schiff & Co. (1); Nolan Biological Laboratories, Inc. (1).
Have GMI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-02-10.
Next steps
- Run an FDA pathway report with predicate devices for product code GMI
- Run a recall and safety report across every GMI manufacturer
- Watch product code GMI 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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