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Campylobacter Quik Chek

FDA UDI

Class I (US FDA UDI)

by Techlab, Inc.

Identity

Trade Name
CAMPYLOBACTER QUIK CHEK FDA UDI
Generic Name
Multiple Campylobacter species antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history. FDA UDI
Model / Reference
T31025 FDA UDI
Description
The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history. FDA UDI

Identifiers

Primary DI / UDI-DI
00857031002479 FDA UDI
510(k) Number
K173217 FDA UDI
FDA Product Code
LQP FDA UDI
GMDN Term
Multiple Campylobacter species antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3110 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: Multiple Campylobacter species antigen IVD, kit, enzyme immunoassay (EIA)

Campylobacter Quik Chek by Techlab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Campylobacter species antigen IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K173217 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Techlab, Inc.

Sources (1)

  • FDA UDI f13ca417-92fd-4f8d-99e3-8578193abf75 34 fields · synced Jun 8, 2026