Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017907743

FEI Number

3017907743

Entity Name

BINX HEALTH, LTD.

City/State/Country

Trowbridge Wiltshire, GB

Establishment Address

Whitehorse Business Park, Derby Court, Trowbridge Wiltshire BA14 OXG, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

binx health, LTD. (Owner Number: 10079710)

Owner / Operator Contact Address

Whitehorse Business Park, Derby Court, Trowbridge, GB-WIL BA14 OXG, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200533

PMA Number

N/A

All Registered Proprietary Names

binx io CT/NG Assay and binx io CT/NG System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2020-12-20
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2020-12-20
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2020-12-20
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2020-12-20

Official Correspondent

Suzy Korreck

US Agent Details

Suzy Korreck Business: binx health Email: suzy.korreck@mybinxhealth.com Phone: (608) 6580811

Related Public Records

Same Entity

binx health, LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

Similar Registrations

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3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
1119779	BECTON, DICKINSON & CO.	SPARKS, MD, US
3007420875	GeneOhm Sciences Canada, ULC.	Quebec, CA
3012598266	MOLECULAR TESTING LABS	Vancouver, WA, US
3004530258	CEPHEID	Sunnyvale, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017907743. Last updated year: 2026. Please use registration number 3017907743 when referencing this establishment in official correspondence.