Antisera, All Mycoplasma Spp.
The Antisera, All Mycoplasma Spp. is a collection of antisera used in laboratory serological testing to detect and identify all species of Mycoplasma, organisms that cause respiratory and urogenital tract infections. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket submission. The product code is GSA, regulated under 21 CFR 866.3375 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GSA
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950073 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM | Oct 17, 1995 | Substantially Equivalent | Shared Systems, Inc. |
| K910833 | COLOR VUE TM- MYCOPLASMA PNEUMONIAE | Jun 24, 1991 | Substantially Equivalent | Seradyn, Inc. |
| K905493 | MERISTAR-MP | Jan 30, 1991 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K903958 | SEROFAST | Dec 21, 1990 | Substantially Equivalent | Intl. Mycoplasma/Mdc Assoc. |
| K883083 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM | Oct 25, 1988 | Substantially Equivalent | Medical Diagnostic Technologies, Inc. |
| K862630 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM | Sep 03, 1986 | Substantially Equivalent | Medical Diagnostic Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.