| Primary Device ID | B085K743M50 |
| NIH Device Record Key | a22f9d2f-8812-4df9-b95a-711a994497ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Audit MicroControls Linearity FD Lipoprotein (a) |
| Version Model Number | K743M-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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B085K743M50 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-28 |
| Device Publish Date | 2025-11-20 |
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