GUDID 05056080500966

REMEL EUROPE LIMITED

Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
Primary Device ID05056080500966
NIH Device Record Key866aa1e3-9586-4211-9a3c-022a459006db
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberR30858801
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
GS105056080500966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GRDAntiserum, Hai, Mumps Virus

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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.