FDA.reportPublic FDA data

SHIGA TOXIN CHEK

Primary DI
00857031002417
Brand
SHIGA TOXIN CHEK
Company
TECHLAB, INC.
Model
T30696
Device 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.
Published
2019-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GMZAntigens, All Types, Escherichia Coli

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMZAntigens, All Types, Escherichia ColiMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121411000SHIGA TOXIN CHEKTechlab Inc., Corporate Research Center2012-10-02GMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857031002417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857031002417008570310024178570310024170857031002417

GMDN Terms#

Term, Definition table
TermDefinition
Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614218634
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857031002547TRI-COMBO PARASITE SCREENT50322019-05-31
00857031002554C. DIFF QUIK CHEK COMPLETET50382019-05-31
00857031002073C. DIFFICILE TOX-B TEST30399U2020-01-24
00857031002530LEUKO EZ VUET50192020-01-24
00857031002561QuickVue TLI H. pylori Test203432019-05-30
00857031002226C. DIFF CHEK - 60T50252019-04-12
00857031002455CAMPYLOBACTER QUIK CHEKT50472019-04-12
00857031002301CRYPTOSPORIDIUM IIPT50142016-08-23
00857031002523H. PYLORI CHEK309962018-09-28
00857031002356LACTOFERRIN EZ VUET50182019-05-31
00857031002585QuickVue TLI Lactoferrin Test203452019-05-30
00857031002189LACTOFERRIN EZ VUE303532019-05-29
00857031002172LEUKO EZ VUET303552019-04-12
00857031002646C. DIFFICILE TOX A/B IIT5015XB2021-05-07
00857031002660C. DIFF CHEK - 60TL50252021-05-03
00857031002639H. PYLORI CHEK T5051B2021-03-12
00857031002066C. DIFFICILE TOXIN ANTITOXIN KITT50002020-01-24
00857031002264C. DIFFICILE TOX-B TESTT50032020-01-24
00857031002622QuickVue TLI H. pylori Stool Antigen Test203432019-09-26
00857031002196SHIGA TOXIN QUIK CHEKT306252019-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733103308Curian Shiga Toxin MERIDIAN BIOSCIENCE, INC.GMZ2023-05-26
05713106818299E. coli reference strain O187Ssi Diagnostica A/SGMZ2021-08-01
05713106818329E. coli reference strain O1Ssi Diagnostica A/SGMZ2021-08-01
05713106818336E. coli reference strain O2Ssi Diagnostica A/SGMZ2021-08-01
05713106818343E. coli reference strain O3Ssi Diagnostica A/SGMZ2021-08-01
05713106818350E. coli reference strain O4Ssi Diagnostica A/SGMZ2021-08-01
05713106818381E. coli reference strain O5Ssi Diagnostica A/SGMZ2021-08-01
05713106818398E. coli reference strain O6Ssi Diagnostica A/SGMZ2021-08-01
05713106818404E. coli reference strain O7Ssi Diagnostica A/SGMZ2021-08-01
05713106818411E. coli reference strain O8Ssi Diagnostica A/SGMZ2021-08-01
05713106818428E. coli reference strain O9Ssi Diagnostica A/SGMZ2021-08-01
05713106818435E. coli reference strain O10Ssi Diagnostica A/SGMZ2021-08-01
05713106818442E. coli reference strain O11Ssi Diagnostica A/SGMZ2021-08-01
05713106818459E. coli reference strain O12Ssi Diagnostica A/SGMZ2021-08-01
05713106818466E. coli reference strain O13Ssi Diagnostica A/SGMZ2021-08-01
05713106818473E. coli reference strain O14Ssi Diagnostica A/SGMZ2021-08-01
05713106818480E. coli reference strain O15Ssi Diagnostica A/SGMZ2021-08-01
05713106818497E. coli reference strain O16Ssi Diagnostica A/SGMZ2021-08-01
05713106818503E. coli reference strain O17Ssi Diagnostica A/SGMZ2021-08-01
05713106818510E. coli reference strain O18abSsi Diagnostica A/SGMZ2021-08-01
05713106818541E. coli reference strain O18acSsi Diagnostica A/SGMZ2021-08-01
05713106818558E. coli reference strain O19abSsi Diagnostica A/SGMZ2021-08-01
05713106818565E. coli reference strain O20Ssi Diagnostica A/SGMZ2021-08-01
05713106818572E. coli reference strain O21Ssi Diagnostica A/SGMZ2021-08-01
05713106818589E. coli reference strain O22Ssi Diagnostica A/SGMZ2021-08-01
05713106818596E. coli reference strain O23Ssi Diagnostica A/SGMZ2021-08-01
05713106818602E. coli reference strain O24Ssi Diagnostica A/SGMZ2021-08-01
05713106818619E. coli reference strain O25Ssi Diagnostica A/SGMZ2021-08-01
05713106818626E. coli reference strain O26Ssi Diagnostica A/SGMZ2021-08-01
05713106818640E. coli reference strain O27Ssi Diagnostica A/SGMZ2021-08-01