| Primary Device ID | B085K908M50 |
| NIH Device Record Key | e4921a3e-f550-499c-8846-b16065a732ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Audit MicroControls Linearity FLQ Cardiac Markers for Ortho Vitros |
| Version Model Number | K908M-5 |
| Company DUNS | 077974989 |
| Company Name | AALTO SCIENTIFIC |
| 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 |