Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K200533 · 2020-04-27

ApplicantBinx Health, Inc.
Decision Date2020-04-27
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

binx io CT/NG Assay and binx io CT/NG System is a medical device manufactured by Binx Health, Inc.. It received FDA 510(k) clearance on 2020-04-27 under approval number K200533. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the binx io CT/NG Assay and binx io CT/NG System?

binx io CT/NG Assay and binx io CT/NG System is a medical device that received FDA 510(k) clearance on 2020-04-27. It is manufactured by Binx Health, Inc.. The 510(k) number is K200533.

When was binx io CT/NG Assay and binx io CT/NG System approved by the FDA?

binx io CT/NG Assay and binx io CT/NG System received FDA 510(k) clearance on 2020-04-27, under approval number K200533.

What company makes binx io CT/NG Assay and binx io CT/NG System?

binx io CT/NG Assay and binx io CT/NG System is manufactured by Binx Health, Inc..

What is the FDA product code for binx io CT/NG Assay and binx io CT/NG System?

The FDA product code for binx io CT/NG Assay and binx io CT/NG System is QEP.

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Binx Health, Inc.

K191352binx health io CT/NG Assay

Related Devices (Code: QEP)

K191352binx health io CT/NG AssayBinx Health, Inc. K190515Aptima Combo 2 Assay (Panther System)Hologic, Inc. K190441Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection KitCepheid K190433cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc. DEN180047Aptima Mycoplasma genitalium AssayHologic, Inc. K200866Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)Hologic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑