QBC Diagnostics 427421

GUDID 00858092006222

QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives and Centrifuge (230V)

DRUCKER DIAGNOSTICS

Biological stain kit IVD
Primary Device ID00858092006222
NIH Device Record Key0c022170-28d0-44c2-b957-24286d1fd3a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameQBC Diagnostics
Version Model Number427421
Catalog Number427421
Company DUNS022156957
Company NameDRUCKER DIAGNOSTICS
Device Count1
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858092006222 [Primary]

FDA Product Code

JSYKit, Identification, Mycobacteria

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-03-11
Device Publish Date2016-09-24

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