| Primary Device ID | 00884883009264 |
| NIH Device Record Key | 0a3a1ac3-5ad0-4f5c-b78d-58a256b2443e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAS OmniCORE Max, Level 2 |
| Version Model Number | OCRM-202 |
| Company DUNS | 122153799 |
| Company Name | Microgenics Corporation |
| 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 | true |
| 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 |
|---|---|
| GS1 | 00884883009264 [Primary] |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-07 |
| Device Publish Date | 2025-06-27 |
| 00884883009257 - MAS OmniCORE Max, Level 1 | 2025-07-07 |
| 00884883009264 - MAS OmniCORE Max, Level 2 | 2025-07-07 |
| 00884883009264 - MAS OmniCORE Max, Level 2 | 2025-07-07 |
| 00884883009271 - MAS OmniCORE Max, Level 3 | 2025-07-07 |
| 00884883009288 - MAS OmniCORE Max, Sample Pack | 2025-07-07 |
| 00884883009219 - MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 1 | 2025-02-10 |
| 00884883009226 - MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 2 | 2025-02-10 |
| 00884883009233 - MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 3 | 2025-02-10 |
| 00884883009240 - MAS Omni-Core II Liquid Assayed Integrated Chemistry Control Sample Pack | 2025-02-10 |