LeukoCount blau

GUDID 04061609000163

BIOANALYTIC GmbH, biomed. Analysentechnik

White blood cell count IVD, reagent
Primary Device ID04061609000163
NIH Device Record Key4984b001-788b-4d80-8eb3-519681e3d32c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeukoCount blau
Version Model Number004013-0100
Company DUNS327536728
Company NameBIOANALYTIC GmbH, biomed. Analysentechnik
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS104061609000163 [Primary]

FDA Product Code

JCGFluid, Diluting, Manual Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-02-06

On-Brand Devices [LeukoCount blau]

04061609000170004013-0500
04061609000163004013-0100

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