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C. Difficile Tox-B Test

FDA UDI

Class I (US FDA UDI)

by Techlab, Inc.

Identity

Trade Name
C. DIFFICILE TOX-B TEST FDA UDI
Generic Name
Clostridium difficile antigen IVD, kit, cell culture assay FDA UDI
Device Name
The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with patient history. FDA UDI
Model / Reference
T5003 FDA UDI
Description
The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with patient history. FDA UDI

Identifiers

Primary DI / UDI-DI
00857031002264 FDA UDI
FDA Product Code
LLH FDA UDI
GMDN Term
Clostridium difficile antigen IVD, kit, cell culture assay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 FDA UDI
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: Clostridium difficile antigen IVD, kit, cell culture assay

C. Difficile Tox-B Test by Techlab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Clostridium difficile antigen IVD, kit, cell culture assay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Techlab, Inc.

Sources (1)

  • FDA UDI cf4aefed-41a7-49ac-8a89-75c5657369e2 33 fields · synced May 30, 2026