Human Fibrinogen BINDARID™ Radial Immunodiffusion

GUDID 05051700010726

THE BINDING SITE GROUP LIMITED

Fibrinogen (Factor I) assay IVD, antibody
Primary Device ID05051700010726
NIH Device Record Key02cb565a-b098-4571-a1a8-5d13e7f2336c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHuman Fibrinogen BINDARID™ Radial Immunodiffusion
Version Model NumberRN056.3
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+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
Emailinfo@bindingsite.co.uk
Phone+4401214569500
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
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
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
GS105051700010726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQJSystem, Fibrinogen Determination

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 THE BINDING SITE GROUP LIMITED

05051700020602 - EXENT® Immunoglobulin Isotypes (GAM) Control Pack2025-12-05
05051700020640 - EXENT® Diluent 12025-12-05
05051700020657 - EXENT® Elution buffer 1 2025-12-05
05051700020664 - EXENT® HCCA MALDI Matrix Pack2025-12-05
05051700020671 - EXENT® Mass calibration standard 1 2025-12-05
05051700020688 - EXENT® Disposable MALDI plate pack 2025-12-05
05051700020695 - EXENT® Wash solution 1 2025-12-05
05051700020886 - EXENT® Analyser2025-12-05

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