Home GUDID 15420045505513 APTIMA
Primary DI 15420045505513
Brand APTIMA
Company Hologic, Inc.
Model TRICHOMONAS VAGINALIS, 100T, IVD (REF)V2
Catalog number 303174; 303209
Published 2016-03-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name OUY Trichomonas vaginalis nucleic acid amplification test system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 15420045505513 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 15420045505513 15420045505513
GMDN Terms# Term, Definition table Term Definition Multiple 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).
Regulatory Flags# DUNS number 050579217 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00382904439248 BD Molecular Urine Transport Kit BECTON, DICKINSON AND COMPANY OUY 2024-05-16 00382904439767 BD Vaginal Panel on BD COR System BECTON, DICKINSON AND COMPANY OUY 2024-04-02 30382904402960 BD Molecular Swab Sample Buffer Tubes BECTON, DICKINSON AND COMPANY OUY 2024-02-26 30382904439232 BD Molecular LBC Sample Buffer Tubes BECTON, DICKINSON AND COMPANY OUY 2024-02-23 00884999051096 Alinity m ABBOTT MOLECULAR INC. OUY 2023-09-14 00810031720064 Visby Medical Sexual Health Test Visby Medical, Inc. OUY 2023-04-19 00810031720071 Visby Medical Power Adapter, Right Angle Visby Medical, Inc. OUY 2023-04-19 15420045514980 APTIMA Hologic, Inc. OUY 2022-07-28 15420045514997 APTIMA Hologic, Inc. OUY 2022-07-28 15420045515000 APTIMA Hologic, Inc. OUY 2022-07-28 15420045515017 APTIMA Hologic, Inc. OUY 2022-07-28 00382904439040 BD CTGCTV2 for BD MAX™ System BECTON, DICKINSON AND COMPANY OUY 2022-07-14 00382904439897 BD COR™ MX BECTON, DICKINSON AND COMPANY OUY 2022-06-16 00382904439798 BD CTGCTV2 BECTON, DICKINSON AND COMPANY OUY 2022-06-08 00884999048898 Alinity m ABBOTT MOLECULAR INC. OUY 2022-05-18 00884999047686 Alinity m ABBOTT MOLECULAR INC. OUY 2022-05-18 00884999047693 Alinity m ABBOTT MOLECULAR INC. OUY 2022-05-18 00884999049314 Alinity m ABBOTT MOLECULAR INC. OUY 2022-05-18 00810031720002 Visby Medical Sexual Health Click Test Visby Medical, Inc. OUY 2021-09-15 00810031720033 Visby Medical Power Adapter Visby Medical, Inc. OUY 2021-09-15 00810031720057 Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack Visby Medical, Inc. OUY 2021-09-15 07332940002954 Xpert Urine Specimen Collection Kit CEPHEID OUY 2018-07-02 00382904429706 BD MAX™ CT/GC/TV BECTON, DICKINSON AND COMPANY OUY 2018-05-25 07332940001001 Xpert TV CEPHEID OUY 2018-01-29 00382904437121 BD MAX™ Vaginal Panel BECTON, DICKINSON AND COMPANY OUY 2017-03-23 30382904433766 BD MAX™ UVE Specimen Collection Kit BECTON, DICKINSON AND COMPANY OUY 2016-10-17 30382904434206 BD MAX™ UVE Sample Buffer Tubes BECTON, DICKINSON AND COMPANY OUY 2016-10-17 00382904438241 BD MAX™ CT/GC/TV Geneohm Sciences Canada Inc OUY 2016-10-17 30014613336396 Solana QUIDEL CORPORATION OUY 2016-09-16 30014613336402 Solana QUIDEL CORPORATION OUY 2016-09-16