Wellcolex E.coli O157

Primary DI
05056080501888
Brand
Wellcolex E.coli O157
Company
REMEL EUROPE LIMITED
Model
R30959501
Published
2021-07-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962028000WELLCOLEX E-COLI OI57 ZC60Murex Diagnostics, Inc.1996-11-01GNA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501888050560805018885056080501888

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
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
05056080500867NAR301633012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10628429001049Prolex E. coli O157 Latex Test Reagent Kit (50 tests)PRO-LAB, INCORPORATEDGNA2022-12-26
10628429001056Prolex E. coli O157 Latex Test Reagent Kit (100 tests)PRO-LAB, INCORPORATEDGNA2022-12-26
10628429001100Prolex E. coli O157 Latex Reagent Control NegativePRO-LAB, INCORPORATEDGNA2022-12-26
10628429001124Prolex E. coli Non-O157 Identification KitPRO-LAB, INCORPORATEDGNA2022-12-26
10628429001131Prolex E. coli O26 Latex ReagentPRO-LAB, INCORPORATEDGNA2022-12-26
10628429001148Prolex E. coli O45 Latex ReagentPRO-LAB, INCORPORATEDGNA2022-12-26
10628429001155Prolex E. coli O103 Latex ReagentPRO-LAB, INCORPORATEDGNA2022-12-26
10628429001162Prolex E. coli O111 Latex ReagentPRO-LAB, INCORPORATEDGNA2022-12-26
10628429001179Prolex E. coli O121 Latex ReagentPRO-LAB, INCORPORATEDGNA2022-12-26
10628429001186Prolex E. coli O145 Latex ReagentPRO-LAB, INCORPORATEDGNA2022-12-26
10628429001193Prolex E. coli Non-O157 Negative Control Latex ReagentPRO-LAB, INCORPORATEDGNA2022-12-26
10628429001209Prolex E. coli O91 Latex ReagentPRO-LAB, INCORPORATEDGNA2022-12-26
10628429001216E. coli O157 Antiserum (3ml)PRO-LAB, INCORPORATEDGNA2022-12-26
00848838026768REMELREMEL, INC.GNA2022-12-23
05032384028511VET-RPLAKITOXOID LIMITEDGNA2022-12-12
05032384013142E. COLI O157 TEST KITOXOID LIMITEDGNA2022-12-08
05032384034420DRYSPOT E. COLI O157OXOID LIMITEDGNA2022-12-04
05713106544013E. coli H4 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544020E. coli H5 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544044E. coli H6 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544068E. coli H7 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544075E. coli H8 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544099E. coli H9 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544105E. coli H10 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544129E. coli H11 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544143E. coli H12 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544167E. coli H14 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544174E. coli H15 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544198E. coli H16 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11
05713106544211E. coli H17 serum, 5 mLSsi Diagnostica A/SGNA2021-08-11