QBC Diagnostics 42900109

GUDID 00858092006055

Refurbished QBC STAR-M Centrifugal Hematology System: Refurbished QBC STAR-M Analyzer; QBC Disposable Starter Kit (20 STAR Tubes)

DRUCKER DIAGNOSTICS

Full blood count IVD, kit, cell count
Primary Device ID00858092006055
NIH Device Record Key077aabfb-5a19-4cc0-bea3-d42f8335a7de
Commercial Distribution StatusIn Commercial Distribution
Brand NameQBC Diagnostics
Version Model Number42900109
Catalog Number42900109
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 Producttrue
Single Usefalse
Lot Batchtrue
Serial Numbertrue
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
GS100858092006055 [Primary]
GS100858092006499 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

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 Date2016-09-24

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