| Primary Device ID | 00852223007010 |
| NIH Device Record Key | f08bb7c7-6e42-481c-9bd7-42ebc8b3ad2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENZYMATIC CHOLESTEROL |
| Version Model Number | 2145-0 |
| Catalog Number | 2145-0 |
| Company DUNS | 155284151 |
| Company Name | STERLING DIAGNOSTICS INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |