| 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 |
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| 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 |