FDA.reportPublic FDA data

Visby Medical Men’s Sexual Health Test

Primary DI
00810031720125
Brand
Visby Medical Men’s Sexual Health Test
Company
Visby Medical, Inc.
Model
PS-400314
Catalog number
PS-400721
Published
2025-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810031720125PrimaryGS10
00810031720132Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810031720125008100317201258100317201250810031720125
00810031720132008100317201328100317201320810031720132

GMDN Terms#

Term, Definition table
TermDefinition
Sexually transmitted infection (STI) testing specimen collection kit IVD, clinicalA collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.

Regulatory Flags#

DUNS number
933894748
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810031720088Visby Medical Women's Sexual Health TestPS-4001452025-08-07
00810031720019Visby Medical Respiratory Health PS-300708PS-4000052025-03-19
10810031720016Visby Medical Respiratory Health PS-300708PS-4000052025-03-19
00810031720002Visby Medical Sexual Health Click Test000175PS-0006882021-09-15
00810031720064Visby Medical Sexual Health TestPS-001402PS-3006812023-04-19
10810031720061Visby Medical Sexual Health TestPS-001402PS-3006812023-04-19
00810031720071Visby Medical Power Adapter, Right AnglePS-000855PS-0008552023-04-19
00810031720033Visby Medical Power AdapterPS-000288PS-0002882021-09-15
00810031720057Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 PackPS-000715PS-0007152021-09-15

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
00382904454357BD COR CTGCTV2 USBECTON, DICKINSON AND COMPANYQEP2025-10-21
05060441760050binx ioBINX HEALTH LIMITEDQEP2025-09-03
25060441760054binx 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