FDA.reportPublic FDA data

Curian Shiga Toxin

Primary DI
00840733103308
Brand
Curian Shiga Toxin
Company
MERIDIAN BIOSCIENCE, INC.
Model
760630
Catalog number
760630
Device description
The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient’s clinical symptoms and history.
Published
2023-05-26
Public version status
Update
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
K222829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222829000Curian® Shiga ToxinMeridian Bioscience, Inc.2023-04-17GMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733103308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733103308008407331033088407331033080840733103308

GMDN Terms#

Term, Definition table
TermDefinition
Escherichia coli antigen IVD, kit, fluorescent immunoassayA 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, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092815364
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
00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102585Hemo-De8013008013002020-12-09
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05713106818657E. coli reference strain O28abSsi Diagnostica A/SGMZ2021-08-01