Anti-Human Globulin, Fta-Abs Test
The Anti-Human Globulin for the FTA-ABS Test is a reagent used in the fluorescent treponemal antibody absorption (FTA-ABS) confirmatory test for syphilis, where it labels patient antibodies bound to Treponema pallidum antigens for visualization under fluorescence microscopy. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMS, regulated under 21 CFR 866.3830 in the Microbiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- GMS
- Device Class
- FDA class 2
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K853122 | IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED | Sep 19, 1985 | Substantially Equivalent | Immuno-Products Industries |
| K843613 | FLUORESCENT TREPONEMEL ANTIBODY-ABSORB | Oct 31, 1984 | Substantially Equivalent | Immuno-Products Industries |
| K781403 | FTA-ABS TEST SYSTEM | Aug 21, 1978 | Substantially Equivalent | Zeus Scientific, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.