Streptex Polyvalent Positive Control

GUDID 05056080501468

REMEL EUROPE LIMITED

Beta-haemolytic Streptococcus serological grouping IVD, control
Primary Device ID05056080501468
NIH Device Record Key315abe33-c52b-4966-bf3f-14d25e0b4a1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameStreptex Polyvalent Positive Control
Version Model NumberR30164601
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+4401256694238
Emailmicrobiology.techsupport.uk@thermofisher.com
Phone+4401256694238
Emailmicrobiology.techsupport.uk@thermofisher.com
Phone+4401256694238
Emailmicrobiology.techsupport.uk@thermofisher.com
Phone+4401256694238
Emailmicrobiology.techsupport.uk@thermofisher.com
Phone+4401256694238
Emailmicrobiology.techsupport.uk@thermofisher.com
Phone+4401256694238
Emailmicrobiology.techsupport.uk@thermofisher.com
Phone+4401256694238
Emailmicrobiology.techsupport.uk@thermofisher.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105056080501468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JTODiscs, Strips And Reagents, Microorganism Differentiation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-29
Device Publish Date2021-07-21

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.