| Primary Device ID | 05051700015592 |
| NIH Device Record Key | 73bc95a2-57ec-48e3-8f8a-05e43e2a114a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Human CH50 Reagent pack for use on the SPAPLUS |
| Version Model Number | NK095.S |
| 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 | true |
| 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 |