Home › TECHLAB, INC. › SHIGA TOXIN QUIK CHEK

SHIGA TOXIN QUIK CHEK

TECHLAB, INC. · Model T30625 · UDI-DI 00857031002196

GMZ Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The SHIGA TOXIN QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. 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 with fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history.

Recalls

Date	Firm	Reason
2006-08-21	Hardy Media Inc Dba Hardy Diag	Performance failure; the product is failing to show pigment development for E. coli 0157.
2002-07-18	Remel, Inc.	A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plu

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.