Identity
- Trade Name
- IFA FTA-ABS Titratable Test System FDA UDI
- Generic Name
- Treponema pallidum total antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The ZEUS IFA Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies to Treponema pallidum, and is intended to be used as an aid in the confirmation of syphilis antibodies. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. FDA UDI
- Model / Reference
- FA7001T FDA UDI
- Description
- The ZEUS IFA Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies to Treponema pallidum, and is intended to be used as an aid in the confirmation of syphilis antibodies. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. FDA UDI
Identifiers
- Catalog Number
- FA7001T FDA UDI
- Primary DI / UDI-DI
- 00845533001502 FDA UDI
- GMDN Term
- Treponema pallidum total antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Treponema pallidum total antibody IVD, kit, fluorescent immunoassay
IFA FTA-ABS Titratable Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Treponema pallidum total antibody IVD, kit, fluorescent immunoassay.
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- AccuDiag ™ — Diagnostic Automation, Inc. · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- BioPlex — Bio-Rad Laboratories · Class II
- BioPlex — Bio-Rad Laboratories · Class II
- QMedix™ — Diagnostic Automation, Inc. · Class II
- IFA FTA-ABS Double Stain Test System — ZEUS SCIENTIFIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI b24454f9-9a47-457d-a5a1-d6ba3061965e 35 fields · synced Jun 6, 2026