OSOM Trich V. 25 Test Kit 181

GUDID 00742860001819

SEKISUI DIAGNOSTICS, LLC

Trichomonas vaginalis antigen IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00742860001819
NIH Device Record Key2036839a-8438-4ef8-bf25-a1d629faae79
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSOM Trich V. 25 Test Kit
Version Model Number181
Catalog Number181
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100742860001819 [Primary]
GS110742860001816 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWZKIT, SCREENING, TRICHOMONAS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

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