OSOM hCG Urine 50 Test Kit 101

GUDID 00742860001017

SEKISUI DIAGNOSTICS, LLC

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00742860001017
NIH Device Record Key8abfc9e2-4625-42fc-88a9-3b1aa37792db
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSOM hCG Urine 50 Test Kit
Version Model Number101
Catalog Number101
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count50
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
GS100742860001017 [Primary]
GS110742860001014 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JHIVisual, pregnancy hCG, prescription use

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 Date2016-09-20

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