PathoDx Extraction Reagent 1 (7ml)

GUDID 05056080501307

REMEL EUROPE LIMITED

Beta-haemolytic Streptococcus serological grouping IVD, reagent
Primary Device ID05056080501307
NIH Device Record Key15fa7929-55e9-4d1c-a8b1-dac56fcf4b46
Commercial Distribution StatusIn Commercial Distribution
Brand NamePathoDx Extraction Reagent 1 (7ml)
Version Model NumberR62050
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
GS105056080501307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GTZAntisera, All Groups, Streptococcus Spp.

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

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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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