Human IgD Liquid Latex Reagent Kit for use on the

GUDID 05051700006255

THE BINDING SITE GROUP LIMITED

Total immunoglobulin D (IgD total) IVD, kit, nephelometry/turbidimetry
Primary Device ID05051700006255
NIH Device Record Keycffd4879-3168-45e3-8a84-3999f5062e61
Commercial Distribution StatusIn Commercial Distribution
Brand NameHuman IgD Liquid Latex Reagent Kit for use on the
Version Model NumberLK013.T
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
GS105051700006255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CZJIgd, 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

Devices Manufactured by THE BINDING SITE GROUP LIMITED

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
05051700010696 - Human Alpha 1 Antitrypsin NL BINDARID™ Kit2023-07-07
05051700015974 - IgD AMR Fluid2023-06-15
05051700015981 - B2M AMR Fluid2023-06-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.