Optilite C-Reactive Protein Calibrator

GUDID 05051700020084

THE BINDING SITE GROUP LIMITED

C-reactive protein (CRP) IVD, calibrator
Primary Device ID05051700020084
NIH Device Record Key63caed9a-165d-4988-8e8a-98ed58c73275
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptilite C-Reactive Protein Calibrator
Version Model NumberNC044.OPT.A
Company DUNS347045614
Company NameTHE BINDING SITE GROUP LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441214569500
Emailinfo@bindingsite.co.uk
Phone+441214569500
Emailinfo@bindingsite.co.uk
Phone+441214569500
Emailinfo@bindingsite.co.uk
Phone+441214569500
Emailinfo@bindingsite.co.uk
Phone+441214569500
Emailinfo@bindingsite.co.uk
Phone+441214569500
Emailinfo@bindingsite.co.uk
Phone+441214569500
Emailinfo@bindingsite.co.uk

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105051700020084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DCNSystem, Test, C-Reactive Protein

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-31

Devices Manufactured by THE BINDING SITE GROUP LIMITED

05051700019392 - Optilite® Low Level Total Protein Controls2024-11-07
05051700020534 - Optilite® Low Level Total Protein Calibrator2024-11-07
05051700020558 - Optilite® Low Level Total Protein Reagent2024-11-07
05051700021036 - Optilite® IgG3 Kit (x10)2023-10-05
05051700021043 - Optilite® IgG4 Kit (x10)2023-10-05
05051700016803 - Freelite® Kappa AMR Check Fluid SD2023-08-17
05051700016810 - Freelite® Lambda AMR Check Fluid SD2023-08-17
05051700002059 - Freelite® Panel Sample Set2023-07-07

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