OSOM Mono 25 Test Kit 145

GUDID 00742860001451

SEKISUI DIAGNOSTICS, LLC

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00742860001451
NIH Device Record Keyaf951767-5688-451b-b923-3a8b01826a6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSOM Mono 25 Test Kit
Version Model Number145
Catalog Number145
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100742860001451 [Primary]
GS110742860001458 [Unit of Use]

FDA Product Code

KTNSYSTEM, TEST, INFECTIOUS MONONUCLEOSIS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-08
Device Publish Date2016-09-16

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