GSA · Antisera, All Mycoplasma Spp.
Microbiology · 21 CFR 866.3375 · Class 1
Overview
| Product Code | GSA |
|---|---|
| Device Name | Antisera, All Mycoplasma Spp. |
| Regulation | 21 CFR 866.3375 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Mycoplasma spp. in serum. Additionally, some of these reagents consist of Mycoplasma spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Mycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Mycoplasma and provides epidemiological information on diseases caused by these microorganisms. Mycoplasma spp. are associated with inflammatory conditions of the urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection with Mycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950073 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM | Shared Systems, Inc. | Oct 17, 1995 | SESE |
| K910833 | COLOR VUE TM- MYCOPLASMA PNEUMONIAE | Seradyn, Inc. | Jun 24, 1991 | SESE |
| K905493 | MERISTAR-MP | Meridian Diagnostics, Inc. | Jan 30, 1991 | SESE |
| K903958 | SEROFAST | Intl. Mycoplasma/Mdc Assoc. | Dec 21, 1990 | SESE |
| K883083 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM | Medical Diagnostic Technologies, Inc. | Oct 25, 1988 | SESE |
| K862630 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM | Medical Diagnostic Technologies, Inc. | Sep 3, 1986 | SESE |
Top Applicants
- Medical Diagnostic Technologies, Inc. — 2 clearances
- Intl. Mycoplasma/Mdc Assoc. — 1 clearance
- Meridian Diagnostics, Inc. — 1 clearance
- Seradyn, Inc. — 1 clearance
- Shared Systems, Inc. — 1 clearance
