Antigens, Ha, Treponema Pallidum
The Treponema Pallidum HA (Hemagglutination) Antigens are reagents used in hemagglutination-based serological tests to detect antibodies against Treponema pallidum, the causative bacterium of syphilis, as part of confirmatory treponemal testing. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMT, 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
- GMT
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K971502 | SERODIA TP-PA | Nov 13, 1997 | Substantially Equivalent | Scimedx Tekfile Services |
| K911640 | OLYMPUS PK TP(TM) SYSTEM, MODIFICATION | Jul 24, 1991 | Substantially Equivalent | Olympus Corp. |
| K911266 | MODIFIED PK TP CONTROL | May 07, 1991 | Substantially Equivalent | Olympus Corp. |
| K905038 | OLYMPUS PK-TP ABSORBENT KIT | May 06, 1991 | Substantially Equivalent | Fujirebio America, Inc. |
| K896410 | CELLOGNOST SYPHILIS H | May 15, 1990 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K893124 | OLYMPUS PK(TM) TP | Nov 17, 1989 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K791897 | BACTO-HATTS | Nov 13, 1979 | Substantially Equivalent | Difco Laboratories, Inc. |
| K791457 | AGGLUTINOTEST-SYPHILIS | Sep 24, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
| K760098 | REAGENT, VDRL | Aug 03, 1976 | Substantially Equivalent | Gamma Biologicals, 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.