# Roche Molecular Systems, Inc. (manufacturer, Branchburg, NJ): 4 new FDA device listings, incl. vaginitis and bacterial vaginosis nucleic acid detection system

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Roche Molecular Systems, Inc. |
| Owner / operator | Roche Diagnostics Operations Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Branchburg, NJ, US |
| New listings | 4 |
| Devices | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System; Dna-Reagents, Neisseria; Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections; Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Product codes | PQA, LSL, QEP, MKZ |
| Device classes | Class I, Class II |
| Medical specialties | Microbiology |
| Brand names | cobas® BV/CV Control Kit; cobas® BV/CV; KIT COBAS LIAT CT/NG IVD; KIT COBAS LIAT CT/NG/MG IVD; KIT COBAS LIAT CT/NG/MG CTL IVD |
| First new listing | 2026-05-21 |
| Latest new listing | 2026-09-10 |
| FDA registration number | 2243471 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.