FDA.reportPublic FDA data

binx io

Primary DI
25060441760054
Brand
binx io
Company
BINX HEALTH LIMITED
Model
V1 (CT/NG)
Catalog number
1.002.101
Device description
binx io CT/NG cartridge
Published
2025-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200533000binx io CT/NG Assay and binx io CT/NG SystemBinx Health, Inc.2020-04-27QEP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25060441760054PackageGS150In Commercial Distribution
05060441760050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2506044176005425060441760054
05060441760050050604417600505060441760050

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
347089851
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060441760036binx ioV1 (CT/NG)5.002.0012025-09-03
05060441760043binx ioV1 (CT/NG)5.012.0012025-09-03
05060441760050binx ioV1 (CT/NG)1.002.1012025-09-03
05060441760005binx ioV13.001.0012025-09-03
15060441760033binx ioV1 (CT/NG)5.002.0012025-09-03
15060441760040binx ioV1 (CT/NG)5.012.0012025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197006056cobas® TV/MGRoche Molecular Systems, Inc.QEP2026-02-24
00875197006063cobas® TV/MG Positive Control KitRoche Molecular Systems, Inc.QEP2026-02-24
00875197006902cobas® TV/MGRoche Molecular Systems, Inc.QEP2026-02-24
00875197006919cobas® TV/MG Positive Control KitRoche Molecular Systems, Inc.QEP2026-02-24
00810031720125Visby Medical Men’s Sexual Health TestVisby Medical, Inc.QEP2025-10-23
00382904454357BD COR CTGCTV2 USBECTON, DICKINSON AND COMPANYQEP2025-10-21
05060441760050binx ioBINX HEALTH LIMITEDQEP2025-09-03
00884999051096Alinity mABBOTT MOLECULAR INC.QEP2023-09-14
15420045514966APTIMAHologic, Inc.QEP2022-07-28
15420045514973APTIMAHologic, Inc.QEP2022-07-28
15420045514980APTIMAHologic, Inc.QEP2022-07-28
15420045514997APTIMAHologic, Inc.QEP2022-07-28
15420045515000APTIMAHologic, Inc.QEP2022-07-28
15420045515017APTIMAHologic, Inc.QEP2022-07-28
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYQEP2022-06-16
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYQEP2022-06-08
00884999048591Alinity mABBOTT MOLECULAR INC.QEP2022-05-19
00884999048607Alinity mABBOTT MOLECULAR INC.QEP2022-05-19
00884999048669Alinity mABBOTT MOLECULAR INC.QEP2022-05-19
00884999048898Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
00884999047686Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
00884999047693Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
00884999049314Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
15420045512795APTIMAHologic, Inc.QEP2020-06-24
15420045512801APTIMAHologic, Inc.QEP2020-06-24
15420045512832Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045512849Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045512894Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045512900Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045509146Aptima®HOLOGIC LTD.QEP2019-01-25