ThromboCount pur

GUDID 04061609000224

BIOANALYTIC GmbH, biomed. Analysentechnik

Platelet count IVD, reagent
Primary Device ID04061609000224
NIH Device Record Key2ace4a00-a4ef-4ba8-8c82-3d79fbdb4060
Commercial Distribution StatusIn Commercial Distribution
Brand NameThromboCount pur
Version Model Number004015-0100
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
GS104061609000224 [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 [ThromboCount pur]

04061609000224004015-0100
04061609000217004015-0050

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