Home GUDID 00742860001819 OSOM Trich V. 25 Test Kit
Primary DI 00742860001819
Brand OSOM Trich V. 25 Test Kit
Company Sekisui Diagnostics, LLC
Model 181
Catalog number 181
Published 2016-09-16
Public version status Update
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 Code Name JWZ KIT, SCREENING, TRICHOMONAS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JWZ Kit, Screening, Trichomonas Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00742860001819 Primary GS1 0 10742860001816 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00742860001819 00742860001819 742860001819 0742860001819 10742860001816 10742860001816
GMDN Terms# Term, Definition table Term Definition Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from the parasitic protozoan Trichomonas vaginalis in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Regulatory Flags# DUNS number 966812344 Device count 25 DM exempt false 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 00848838011535 REMEL REMEL, INC. JWZ 2023-01-04 00742860100123 OSOM Trich V. 5 Test Kit Sekisui Diagnostics, LLC JWZ 2016-09-20 00742860100130 OSOM Trich.10T Cntrl Kit Sekisui Diagnostics, LLC JWZ 2016-09-16