| Primary Device ID | 04015630909032 |
| NIH Device Record Key | 85588b60-c087-4ae4-9173-a6e8ddcd2c77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Myoglobin Control Set |
| Version Model Number | 11730835216 |
| Catalog Number | 11730835216 |
| Company DUNS | 315028860 |
| Company Name | Roche Diagnostics GmbH |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04015630909032 [Primary] |
| JJX | Single (specified) analyte controls (assayed and unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-26 |
| Device Publish Date | 2021-01-18 |
| 04015630926091 - Testosterone II CalSet II | 2026-03-03 |
| 07613336218402 - Elecsys LH | 2026-02-27 |
| 07613336236499 - Elecsys BRAHMS PCT | 2026-02-27 |
| 04015630911707 - Elecsys Myoglobin STAT CalSet | 2026-02-23 |
| 04015630918805 - Cfas PUC | 2026-02-23 |
| 04015630919932 - C.f.a.s. PAC | 2026-02-23 |
| 04015630936373 - Cfas Proteins | 2026-02-23 |
| 04015630939060 - Elecsys Myoglobin Immunoassay | 2026-02-23 |