| Primary Device ID | 00875197006889 |
| NIH Device Record Key | fee55e93-872a-47f3-ab0f-3c6f52ba9f0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cobas HPV |
| Version Model Number | 09040544190 |
| Catalog Number | 09040544190 |
| Company DUNS | 071674100 |
| Company Name | Roche Molecular Systems, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 00875197006889 [Primary] |
| MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-13 |
| Device Publish Date | 2024-06-05 |
| 00875197006896 - cobas HPV Positive Control Kit | 2024-06-14 |
| 00875197006889 - cobas HPV | 2024-06-13 |
| 00875197006889 - cobas HPV | 2024-06-13 |
| 04015630936540 - cobas p630 Pre-Analytical Pipettor | 2022-09-16 |
| 04015630936557 - DOCKING STATION SHORT | 2022-09-16 |
| 00875197006445 - cobas® NHP Negative Control Kit | 2022-08-09 |
| 04015630929009 - cobas x 480 Analyzer | 2022-06-10 |
| 00875197006391 - cobas® HCV | 2021-12-22 |
| 00875197006407 - cobas® HIV-1 | 2021-12-22 |