FDA product code GSB: Antigens, Cf, All, Mycoplasma Spp.
GSB is the FDA product code for antigens, cf, all, mycoplasma spp.. It is a Class I device, regulated under 21 CFR 866.3375 and reviewed by the Microbiology panel. FDA has cleared 5 510(k) submissions under GSB, from 5 different applicants. The average 510(k) review took 52 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Cf, All, Mycoplasma Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3375 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GSB clearance
Top GSB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microbix Biosystems, Inc. | 1 | 1985-08-01 |
| Institute Virion , Ltd. | 1 | 1984-10-25 |
| Hillcrest Biologicals | 1 | 1984-02-27 |
| Miles Laboratories, Inc. | 1 | 1983-09-20 |
| Orion Diagnostica, Inc. | 1 | 1980-12-31 |
Most recent GSB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K852933 | Microbix Biosystems, Inc. | MYCOPLASMA SPP SEROLOGICAL REAGENTS | 1985-08-01 | 23 |
| K843664 | Institute Virion , Ltd. | MYCOPLASMA PNEUMONIAE | 1984-10-25 | 38 |
| K834338 | Hillcrest Biologicals | MYCOPLASMA PNEUMONIAE CF ANTIGEN | 1984-02-27 | 77 |
| K832132 | Miles Laboratories, Inc. | SERA-TEK MYCOPLASMA ANTIBODY TEST | 1983-09-20 | 81 |
| K802934 | Orion Diagnostica, Inc. | MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL | 1980-12-31 | 42 |
Recalls for GSB devices
openFDA lists no recalls for product code GSB.
Frequently asked questions
What is FDA product code GSB?
GSB is the FDA product code for antigens, cf, all, mycoplasma spp.. It is a Class I device, regulated under 21 CFR 866.3375 and reviewed by the Microbiology panel.
What device class is GSB?
Class I, regulation 21 CFR 866.3375. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GSB?
Across 5 cleared submissions the average was 52 days from receipt to decision (median 42).
Which companies have the most GSB clearances?
Microbix Biosystems, Inc. (1); Institute Virion , Ltd. (1); Hillcrest Biologicals (1); Miles Laboratories, Inc. (1); Orion Diagnostica, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GSB
- Run a recall and safety report across every GSB manufacturer
- Watch product code GSB 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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