FDA.reportPublic FDA data

Wellcolex E.coli O157:H7

Primary DI
05056080501895
Brand
Wellcolex E.coli O157:H7
Company
REMEL EUROPE LIMITED
Model
R30959601
Published
2021-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K971663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971663000WELLCOLEX E.COLI O157:H7Murex Biotech , Ltd.1997-12-30GMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501895050560805018955056080501895

GMDN Terms#

Term, Definition table
TermDefinition
Escherichia coli antigen IVD, kit, agglutinationA 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 agglutination method.

Contacts#

Phone, Email table
PhoneEmail
+4401256694238microbiology.techsupport.uk@thermofisher.com

Regulatory Flags#

DUNS number
232600853
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056080500928Shigella boydii polyvalent 1 (1-6) Agglutinating SerumR301639012026-05-05
05056080501024NAR301650012016-12-09
05056080501888Wellcolex E.coli O157R309595012021-07-21
05056080501598Proteus OX2 Agglutinating SerumR301657012021-07-21
05056080500065NAR308550012016-09-24
05056080500126NAR308553012016-09-24
05056080500317NAR309577012016-09-24
05056080500324NAR309578012016-09-24
05056080500331NAR309579012016-09-24
05056080500348NAR309580012016-09-24
05056080500379NAR309583012016-09-24
05056080500409NAR309586012016-09-24
05056080500591NAR301606012016-09-24
05056080500607NAR301607012016-09-24
05056080500614NAR301608012016-09-24
05056080500638NAR301610012016-09-24
05056080500645NAR301611012016-09-24
05056080500652NAR301612012016-09-24
05056080500713NAR301618012016-09-24
05056080500768NAR301623012016-09-24

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