| Primary Device ID | 07613336149850 |
| NIH Device Record Key | 90509040-7855-4463-82d1-1898d6e26d78 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CalSet Phospho-Tau (181P) |
| Version Model Number | 07357044190 |
| Catalog Number | 07357044190 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613336149850 [Primary] |
| JIT | Calibrator, secondary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-13 |
| Device Publish Date | 2022-12-13 |
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