GUDID 05056080500492

REMEL EUROPE LIMITED

Multiple Shigella species culture isolate antigen IVD, kit, agglutination
Primary Device ID05056080500492
NIH Device Record Keyc0fabfec-2202-4068-8768-ea3df69cd1e3
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberR30858401
Company DUNS232600853
Company NameREMEL EUROPE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS105056080500492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GNBAntisera, All Types, Shigella Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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