Antigens, Cf, All, Mycoplasma Spp.
The Antigens, CF, All, Mycoplasma Spp. is a set of complement fixation antigens covering all Mycoplasma species, used in laboratory testing to detect antibody responses associated with mycoplasmal infections. As an FDA Class 1 device, it presents minimal risk and requires only general controls without any premarket clearance. Regulated under 21 CFR 866.3375 with product code GSB in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GSB
- Device Class
- FDA class 1
- Regulation Number
- 866.3375
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K852933 | MYCOPLASMA SPP SEROLOGICAL REAGENTS | Aug 01, 1985 | Substantially Equivalent | Microbix Biosystems, Inc. |
| K843664 | MYCOPLASMA PNEUMONIAE | Oct 25, 1984 | Substantially Equivalent | Institute Virion , Ltd. |
| K834338 | MYCOPLASMA PNEUMONIAE CF ANTIGEN | Feb 27, 1984 | Substantially Equivalent | Hillcrest Biologicals |
| K832132 | SERA-TEK MYCOPLASMA ANTIBODY TEST | Sep 20, 1983 | Substantially Equivalent | Miles Laboratories, Inc. |
| K802934 | MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL | Dec 31, 1980 | Substantially Equivalent | Orion Diagnostica, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.