Primary Device ID | 07613336179505 |
NIH Device Record Key | 0015a8f6-6f99-401c-9a92-36ca2945927b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | cobas pro SB |
Version Model Number | 09205675001 |
Catalog Number | 09205675001 |
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 | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
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 | 07613336179505 [Primary] |
JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-13 |
Device Publish Date | 2021-09-03 |
07613336224816 - ONLINE TDM Methotrexate | 2024-04-02 |
07613336224823 - ONLINE TDM Methotrexate | 2024-04-02 |
07613336224830 - MTX Calibrator | 2024-04-02 |
07613336217689 - Elecsys ProBNP II | 2024-02-27 |
04015630929702 - cobas Elecsys AntiTPO | 2024-02-16 |
04015630939626 - Elecsys Anti-TPO | 2024-02-16 |
04015630899548 - Elecsys CalSet TUptake | 2024-02-05 |
04015630899579 - Elecsys Tuptake Assay | 2024-02-05 |