Identity
- Trade Name
- TPHA Screen Diluent FDA UDI
- Generic Name
- Treponema pallidum total antibody IVD, kit, agglutination FDA UDI
- Device Name
- TPHA Screen Diluent is a ready for use isotonic saline solution used to dilute sample plasma or serum, and control material, when testing with the TPHA Screen on an automated Blood Bank system. The product configuration is ten (10) vials. FDA UDI
- Model / Reference
- 0066827 FDA UDI
- Description
- TPHA Screen Diluent is a ready for use isotonic saline solution used to dilute sample plasma or serum, and control material, when testing with the TPHA Screen on an automated Blood Bank system. The product configuration is ten (10) vials. FDA UDI
Identifiers
- Catalog Number
- 0066827 FDA UDI
- Primary DI / UDI-DI
- 10888234001492 FDA UDI
- FDA Product Code
- MYR FDA UDI
- GMDN Term
- Treponema pallidum total antibody IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3830 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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, agglutination
TPHA Screen Diluent by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Treponema pallidum total antibody IVD, kit, agglutination.
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class II
- TPHA Screen — IMMUCOR, INC. · Class II
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI 236b1c21-0bfc-4654-9659-b26050bd765a 36 fields · synced May 30, 2026