C. Diff Quik Chek Complete

EUDAMEDFDA UDIFDA 510(k)

Class B (EU MDR)

Ref T30525C510(k) K082499

by TECHLAB, Inc.

Identity

Trade Name: C. DIFF QUIK CHEK COMPLETE FDA UDI
Generic Name: Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: C. DIFF QUIK CHEK COMPLETE EUDAMED
The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. FDA UDI
Model / Reference: T30525C EUDAMEDFDA UDI
Description: The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. FDA UDI

Identifiers

Primary DI / UDI-DI: 00857031002059 EUDAMEDFDA UDI
Basic UDI-DI: 857031002CDIFFAGTOX001SJ EUDAMED
Direct Marketing DI: 00857031002059 EUDAMED
510(k) Number: K082499 FDA UDI
FDA Product Code: LLH FDA UDI
EMDN Code: W0105011803 C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION EUDAMED
GMDN Term: Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class B EUDAMED
Class I FDA UDI
Regulation Number: 866.2660 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

C. Diff Quik Chek Complete by Techlab, Inc. — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K053572	Class B	Active
FDA 510(k)	United States	FDA_510K	K082499	Class B	Active
EUDAMED	European Union	CE/IVDR	857031002CDIFFAGTOX001SJ	Class B	Active

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Manufacturer

Manufacturer: TECHLAB, Inc.
EUDAMED SRN: US-MF-000008412
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (3)

EUDAMED 630ed1a6-7a6d-41e7-9f0a-05cb2ba24611 85 fields · synced Jun 18, 2026
FDA UDI ea66c3a0-8680-4fd9-b381-6686a07a3890 34 fields · synced May 27, 2026
FDA 510(k) K053572 1 fields · synced May 18, 2026