Data / Medical devices / United Kingdom / Binx Health, Ltd.
Binx Health, Ltd.: FDA-registered device maker in Trowbridge Wiltshire, United Kingdom, 1 510(k) clearance
Binx Health, Ltd. is registered with the FDA (registration 3017907743) in Trowbridge Wiltshire, United Kingdom. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 27, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017907743
- Address
- Whitehorse Business Park Derby Court, Trowbridge Wiltshire, United Kingdom, BA14 OXG
- Owner or operator
- binx health, LTD. (10079710)
- Roles
- Manufacturer
- First device listed
- December 20, 2020
- Registered through
- 2026
- Brand names listed
- binx io CT/NG Assay and binx io CT/NG System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | 1 | Manufacturer | accessdata.fda.gov |
| Dna-Reagents, Neisseria | LSL | 2 | Manufacturer | accessdata.fda.gov |
| Instrumentation For Clinical Multiplex Test Systems | NSU | 2 | Manufacturer | accessdata.fda.gov |
| Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | QEP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 27, 2020 | K200533 | binx io CT/NG Assay and binx io CT/NG System | QEP | Substantially Equivalent | Binx Health, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- All makers of Dna Probe, Nucleic Acid Amplification, Chlamydia
- All makers of Dna-Reagents, Neisseria
- All makers of Instrumentation For Clinical Multiplex Test Systems
Updated April 27, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.