Antisera, Fluorescent, All Types, Staphylococcus Spp.
The Antisera, Fluorescent, All Types, Staphylococcus Spp. is a set of fluorescent antisera used in immunofluorescence assays to detect and identify all species of Staphylococcus in clinical specimens, supporting the diagnosis of staphylococcal infections. It is an FDA Class 1 device, the lowest risk category, requiring only general controls and no premarket clearance. The product code is GTN, regulated under 21 CFR 866.3700 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GTN
- Device Class
- FDA class 1
- Regulation Number
- 866.3700
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K855236 | DIAGNOSTIC REAGENT TST-RPLA | Nov 04, 1986 | Substantially Equivalent | Oxoid U.S.A., Inc. |
| K855233 | DIAGNOSTIC REAGENT SET-RPLA | Nov 04, 1986 | Substantially Equivalent | Oxoid U.S.A., Inc. |
| K851949 | STAPHAUREX ZL30 | May 22, 1985 | Substantially Equivalent | Wellcome Diagnostics |
| K791453 | AGGLUTINOTEST-STAPHYLOLISIN | Sep 24, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
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.