| Primary Device ID | 00875197007350 |
| NIH Device Record Key | fc505c73-dc21-4157-9f1a-91e3f9563652 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cobas liat Bordetella panel nucleic acid test |
| Version Model Number | 09857664190 |
| Catalog Number | 09857664190 |
| 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 | 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 | 00875197007350 [Primary] |
| OZZ | Bordetella pertussis dna assay system |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-03 |
| Device Publish Date | 2026-02-23 |
| 00875197005677 - cobas® Cdiff | 2026-03-03 |
| 00875197005684 - cobas® Cdiff Control Kit | 2026-03-03 |
| 00875197007350 - cobas liat Bordetella panel nucleic acid test | 2026-03-03 |
| 00875197007350 - cobas liat Bordetella panel nucleic acid test | 2026-03-03 |
| 00875197007367 - cobas liat Bordetella panel control kit | 2026-03-03 |
| 00875197006285 - cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | 2025-06-05 |
| 00875197006292 - cobas liat SARS-CoV-2 v2 nucleic acid test | 2025-06-05 |
| 00875197007299 - cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | 2025-06-05 |
| 00875197007305 - cobas liat SARS-CoV-2, Influenza A/B & RSV control kit | 2025-06-05 |