# Becton, Dickinson & Co. (manufacturer, Sparks, MD): 2 new FDA device listings, incl. device for home collection and transport of vaginal specimens by lay u

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Becton, Dickinson & Co. |
| Owner / operator | Becton Dickinson and Company |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | Sparks, MD, US |
| New listings | 2 |
| Devices | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay; System, Blood Culturing |
| Product codes | SEP, MDB |
| Device classes | Class I, Class II |
| Medical specialties | Microbiology |
| Brand names | Onclarity™ Self-Collection Kit-Viper™ LT; Onclarity™ Self-Collection Kit-COR™; BD BACTEC™ FXI Culture System Workflow Module; BD BACTEC™ FXI Culture System Analyzer Module; BD BACTEC™ FXI 480/960 Culture System Software |
| First new listing | 2026-05-29 |
| Latest new listing | 2026-06-11 |
| FDA registration number | 1119779 |
| 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.
- 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.