Thrombo-TIC 1:100 pur

GUDID 04061609000231

BIOANALYTIC GmbH, biomed. Analysentechnik

Platelet count IVD, reagent
Primary Device ID04061609000231
NIH Device Record Keyf9a23adb-229b-4d52-8c24-9f0946019e56
Commercial Distribution StatusIn Commercial Distribution
Brand NameThrombo-TIC 1:100 pur
Version Model Number004015-6010
Company DUNS327536728
Company NameBIOANALYTIC GmbH, biomed. Analysentechnik
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS104061609000231 [Primary]
GS104061609000606 [Unit of Use]

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 [Thrombo-TIC 1:100 pur]

04061609000699004015-6011DMD
04061609000231004015-6010
04061609000194004015-0006

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