Antigen, Treponema Pallidum For Fta-Abs Test
Antigen, Treponema Pallidum for FTA-ABS Test is a microbiological reagent containing Treponema pallidum antigen used in the fluorescent treponemal antibody absorption (FTA-ABS) test, a confirmatory serological assay for syphilis diagnosis. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JWL, regulated under 21 CFR 866.3830, and falls within the Microbiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- JWL
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K831296 | POLYCHACO FIA-ABS TEST FOR SYPHILIS | Jul 26, 1983 | Substantially Equivalent | Parasitic Disease Consultants |
| K802276 | FTA-ABS BIOPAK | Oct 23, 1980 | Substantially Equivalent | Bioware Products |
| K801959 | FTA-ABS TEST | Oct 23, 1980 | Substantially Equivalent | Immuno-Diagnostic Products, Inc. |
| K801928 | LAB-TEK FTA-ABS KIT | Aug 20, 1980 | Substantially Equivalent | Miles Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.