Human Prealbumin BINDARID™ Radial Immunodiffusion

GUDID 05051700010771

THE BINDING SITE GROUP LIMITED

Prealbumin (transthyretin) IVD, antibody
Primary Device ID05051700010771
NIH Device Record Key2a9858bc-1d12-4205-90b3-bc8b03479d14
Commercial Distribution StatusIn Commercial Distribution
Brand NameHuman Prealbumin BINDARID™ Radial Immunodiffusion
Version Model NumberRN066.3
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105051700010771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JZJPrealbumin, Antigen, Antiserum, Control

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

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