Home GUDID 00810031720088 Visby Medical Women's Sexual Health Test
Primary DI 00810031720088
Brand Visby Medical Women's Sexual Health Test
Company Visby Medical, Inc.
Model PS-400145
Published 2025-08-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true Product Codes# Code, Name table Code Name SEA Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SEA Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810031720088 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810031720088 00810031720088 810031720088 0810031720088
GMDN Terms# Term, Definition table Term Definition Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical A 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 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810031720125 Visby Medical Men’s Sexual Health Test PS-400314 PS-400721 2025-10-23 00810031720019 Visby Medical Respiratory Health PS-300708 PS-400005 2025-03-19 10810031720016 Visby Medical Respiratory Health PS-300708 PS-400005 2025-03-19 00810031720002 Visby Medical Sexual Health Click Test 000175 PS-000688 2021-09-15 00810031720064 Visby Medical Sexual Health Test PS-001402 PS-300681 2023-04-19 10810031720061 Visby Medical Sexual Health Test PS-001402 PS-300681 2023-04-19 00810031720071 Visby Medical Power Adapter, Right Angle PS-000855 PS-000855 2023-04-19 00810031720033 Visby Medical Power Adapter PS-000288 PS-000288 2021-09-15 00810031720057 Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack PS-000715 PS-000715 2021-09-15