OSOM Trich.10T Cntrl Kit 182

GUDID 00742860100130

SEKISUI DIAGNOSTICS, LLC

Trichomonas vaginalis antigen IVD, control
Primary Device ID00742860100130
NIH Device Record Key31678ae9-3f7a-49dd-92b3-6a3701ae197e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSOM Trich.10T Cntrl Kit
Version Model Number182
Catalog Number182
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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
GS100742860100130 [Primary]
GS110742860100137 [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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