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TPHA Screen

FDA UDI

Class II (US FDA UDI)

by Immucor, Inc.

Identity

Trade Name
TPHA Screen FDA UDI
Generic Name
Treponema pallidum total antibody IVD, kit, agglutination FDA UDI
Device Name
TPHA Screen is used in the qualitative screening of blood donors for the detection of IgG and IgM antibodies to Treponema pallidum in human serum and EDTA plasma by passive hemagglutination using an automated Blood Bank system. The product configuration is ten (10) vials. FDA UDI
Model / Reference
0066826 FDA UDI
Description
TPHA Screen is used in the qualitative screening of blood donors for the detection of IgG and IgM antibodies to Treponema pallidum in human serum and EDTA plasma by passive hemagglutination using an automated Blood Bank system. The product configuration is ten (10) vials. FDA UDI

Identifiers

Catalog Number
0066826 FDA UDI
Primary DI / UDI-DI
10888234001485 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 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immucor, Inc.

Sources (1)

  • FDA UDI 64a52ad9-874c-42fe-9dd3-00c8f863ebcf 36 fields · synced May 29, 2026