GUDID 05056080501048

REMEL EUROPE LIMITED

Vibrio cholerae culture isolate antigen (multiple serotype) IVD, kit, agglutination
Primary Device ID05056080501048
NIH Device Record Keyfa3f82ae-294b-4042-88ab-4f73f8faccfb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberR30165201
Company DUNS232600853
Company NameREMEL EUROPE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401322295600
EmailITechnicalSupport@remel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105056080501048 [Primary]

FDA Product Code

GSOAntigens (Febrile), Agglutination, Brucella Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-09

Devices Manufactured by REMEL EUROPE LIMITED

05056080500775 - Salmonella H z Agglutinating Sera2021-07-29
05056080501031 - Vibrio cholerae Inaba Agglutinating Sera2021-07-29
05056080501239 - PathoDx Strep Grouping Kit2021-07-29
05056080501246 - PathoDx Strep A Grouping Latex2021-07-29
05056080501253 - PathoDx Strep B Grouping Latex2021-07-29
05056080501260 - PathoDx Strep C Grouping Latex2021-07-29
05056080501277 - PathoDx Strep F Grouping Latex2021-07-29
05056080501284 - PathoDx Strep G Grouping Latex2021-07-29

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