Primary Device ID | 05051700020183 |
NIH Device Record Key | a3885f9b-48de-40ca-8dbc-24bca7bf0426 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Optilite IgM CSF Kit |
Version Model Number | LK012.L.OPT.A |
Company DUNS | 347045614 |
Company Name | THE BINDING SITE GROUP LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +441214569500 |
INFO@BINDINGSITE.COM |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05051700020183 [Primary] |
CFN | Method, Nephelometric, Immunoglobulins (G, A, M) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-02-10 |
Device Publish Date | 2020-01-31 |
05051700021036 - Optilite® IgG3 Kit (x10) | 2023-10-05 |
05051700021043 - Optilite® IgG4 Kit (x10) | 2023-10-05 |
05051700016803 - Freelite® Kappa AMR Check Fluid SD | 2023-08-17 |
05051700016810 - Freelite® Lambda AMR Check Fluid SD | 2023-08-17 |
05051700002059 - Freelite® Panel Sample Set | 2023-07-07 |
05051700010696 - Human Alpha 1 Antitrypsin NL BINDARID™ Kit | 2023-07-07 |
05051700015974 - IgD AMR Fluid | 2023-06-15 |
05051700015981 - B2M AMR Fluid | 2023-06-15 |