Roche Molecular Systems, Inc. (manufacturer, Branchburg, NJ): 4 new FDA device listings, incl. vaginitis and bacterial vaginosis nucleic acid detection system
Roche Molecular Systems, Inc. (Branchburg, New Jersey): 4 new FDA device listings, incl. vaginitis and bacterial vaginosis nucleic acid detection system. Its amount of 4 is above the median of 1 (83rd percentile). Dated 55 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 4 · 83th percentile of 2,570 DeviceEstablishmentPulse records · 4.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 48 related NJ DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 83th of 2,570 (median 1, 4.0x median) |
| Peer records CSV (49 NJ records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-10
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Roche Molecular Systems, Inc. and 49 New Jersey peers
- New Jersey DeviceEstablishmentPulse records like this one: 49
- Roche Molecular Systems, Inc.'s amount: 83rd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New Jersey peer: $9,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 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.
What is the DeviceEstablishmentPulse record for Roche Molecular Systems, Inc. in Branchburg, New Jersey?
Roche Molecular Systems, Inc. (Branchburg, NJ), a manufacturer, added 4 FDA device listings between 2026-05-21 and 2026-09-10.
How does Roche Molecular Systems, Inc. compare to other New Jersey DeviceEstablishmentPulse records?
Its amount of 4 sits in the upper half (83th percentile) of 2,570 records; the median is 1. It is 55 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
Roche Molecular Systems, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Roche Molecular Systems, Inc. | Branchburg, NJ | 4 | 83rd | 2026-09-10 |
| Piraeus Medical, Inc. | Maple Grove, MN | 4 | 83rd | 2026-10-12 |
| Inquis Medical, Inc. | Menlo Park, CA | 5 | 87th | 2026-10-16 |
| Beacon Biosignals, Inc. | Boston, MA | 3 | 77th | 2026-10-16 |
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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.