← Back to catalogue

Shiga Toxin Chek

FDA UDI

Class I (US FDA UDI)

by Techlab, Inc.

Identity

Trade Name
SHIGA TOXIN CHEK FDA UDI
Generic Name
Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The SHIGA TOXIN CHEK test is an enzyme immunoassay for the simultaneous qualitative detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga Toxin producing Escherichia coli (STEC). It may be used directly with human fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history. FDA UDI
Model / Reference
T30696 FDA UDI
Description
The SHIGA TOXIN CHEK test is an enzyme immunoassay for the simultaneous qualitative detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga Toxin producing Escherichia coli (STEC). It may be used directly with human fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history. FDA UDI

Identifiers

Primary DI / UDI-DI
00857031002417 FDA UDI
510(k) Number
K121411 FDA UDI
FDA Product Code
GMZ FDA UDI
GMDN Term
Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3255 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: Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)

The SHIGA TOXIN CHEK test is an enzyme immunoassay for the simultaneous qualitative detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test, intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga Toxin producing Escherichia coli (STEC).

Similar devices

Also classified as Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Techlab, Inc.

Sources (1)

  • FDA UDI f52f9d3b-c9f8-4012-91dd-53843f661f4e 34 fields · synced Jul 12, 2026