| Primary Device ID | 04061609000170 |
| NIH Device Record Key | be6648bb-cacb-4d57-b500-e2a2d1b4956e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LeukoCount blau |
| Version Model Number | 004013-0500 |
| Company DUNS | 327536728 |
| Company Name | BIOANALYTIC GmbH, biomed. Analysentechnik |
| 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 | 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 | false |
| OTC Over-The-Counter | false |