| Primary Device ID | 00817089020825 |
| NIH Device Record Key | f622db21-91ad-4dcf-a38d-7dfa970d109f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adenosine Deaminase Assay Kit |
| Version Model Number | DZ117A-K |
| Company DUNS | 080507219 |
| Company Name | DIAZYME LABORATORIES, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |