GUDID 05056080500263

REMEL EUROPE LIMITED

Multiple Salmonella species culture isolate antigen IVD, kit, agglutination
Primary Device ID05056080500263
NIH Device Record Key99b493e9-d06d-491a-b9e4-1b6dff04f910
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberR30957201
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
GS105056080500263 [Primary]

FDA Product Code

GRMAntisera, All Groups, Salmonella 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 Date2016-09-24

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05056080501253 - PathoDx Strep B Grouping Latex2021-07-29
05056080501260 - PathoDx Strep C Grouping Latex2021-07-29
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