EryCount pur

GUDID 04061609000125

BIOANALYTIC GmbH, biomed. Analysentechnik

Red blood cell count IVD, reagent
Primary Device ID04061609000125
NIH Device Record Keydc3f94fd-6f78-4113-a58c-71240404c0e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEryCount pur
Version Model Number004012-0500
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 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
GS104061609000125 [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 [EryCount pur]

04061609000125004012-0500
04061609000118004012-0100

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