Human IgG1 Subclass Liquid Reagent Kit for use on

GUDID 05051700007597

THE BINDING SITE GROUP LIMITED

Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Primary Device ID05051700007597
NIH Device Record Keydaad158b-350f-4f6e-8db6-219606b654fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameHuman IgG1 Subclass Liquid Reagent Kit for use on
Version Model NumberNK006.H
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
GS105051700007597 [Primary]

FDA Product Code

DFZIgg (Gamma Chain Specific), Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [Human IgG1 Subclass Liquid Reagent Kit for use on ]

05051700016377NK006.10S
05051700007634NK006.TB
05051700007627NK006.T
05051700007603NK006.IM
05051700007597NK006.H
05051700007566NK006.AU

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