| Primary Device ID | B085K087M60 |
| NIH Device Record Key | f67d24b7-20b1-4f47-8774-b7cc074c9bf3 |
| Commercial Distribution Discontinuation | 2022-08-28 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Audit MicroControls Control LQ COVID-19 IgG + IgM Antibodies |
| Version Model Number | K087M-6 |
| 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 | B085K087M60 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-10 |
| Device Publish Date | 2020-11-12 |
| B085K087M60 - Audit MicroControls Control LQ COVID-19 IgG + IgM Antibodies | 2025-12-10 |
| B085K087M60 - Audit MicroControls Control LQ COVID-19 IgG + IgM Antibodies | 2025-12-10 |
| B085K932M50 - Audit MicroControls Linearity FLQ Troponin T for Roche Systems | 2025-12-10 |
| B085K815M50 - Audit MicroControls Linearity FD ISE for Siemens Atellica | 2025-12-04 |
| B085K939M100 - Audit MicroControls Linearity FD Tumor Markers for Abbott Systems | 2025-12-04 |
| B085K743M50 - Audit MicroControls Linearity FD Lipoprotein (a) | 2025-11-28 |
| B085K829M100 - Audit MicroControls Linearity FD Urine Chemistry for Beckman AU | 2025-11-28 |
| B085K922M50 - Audit MicroControls Linearity FLQ Special Diabetes for Roche Systems | 2025-09-22 |
| B085K836M50 - Audit MicroControls Linearity FD BNP for Abbott Systems | 2025-07-30 |