BD ProbeTec Neisseria Gonorrhoeae GC Qx Amplified DNA Assay
by Becton, Dickinson & CO 4 variants
510(k) K140448
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140448 | Date20 May 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LSL
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3390
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The BD ProbeTec Neisseria gonorrhoeae GC Qx Amplified DNA Assay is a DNA reagent kit designed for the direct, qualitative detection of Neisseria gonorrhoeae DNA. It utilizes Strand Displacement Amplification technology to identify the presence of the bacteria in clinical specimens.
This assay is intended for use with the BD Viper System in Extracted Mode or the BD Viper LT System for testing clinician-collected female endocervical and male urethral swab specimens, as well as patient-collected vaginal swab specimens. The device has received FDA 510k clearance under the microbiology specialty.
Other devices from Becton, Dickinson & Co.
Questions
AI-generated answers, 24 Sep 2026
What is the primary purpose of the BD ProbeTec GC Qx DNA Assay?
This assay is designed for the direct, qualitative detection of Neisseria gonorrhoeae DNA in clinical specimens. It utilizes Strand Displacement Amplification technology to identify the presence of the bacteria.
Which clinical specimens are compatible with this assay?
The assay is intended for use with clinician-collected female endocervical and male urethral swab specimens, as well as patient-collected vaginal swab specimens.
What laboratory systems are required to run this assay?
The assay is intended for use with the BD Viper System in Extracted Mode or the BD Viper LT System to ensure proper processing and analysis of the clinical specimens.
What is the regulatory status of this device?
The BD ProbeTec Neisseria gonorrhoeae GC Qx Amplified DNA Assay has received FDA 510k clearance under the microbiology specialty, as indicated by the K140448 submission.