Hema-Trol

GUDID 00884883005853

Microgenics Corporation

Haemoglobin detection IVD, control
Primary Device ID00884883005853
NIH Device Record Keyb6e3eff2-02c8-4801-bfee-17f359d5a3d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHema-Trol
Version Model NumberHYC84668
Company DUNS122153799
Company NameMicrogenics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100884883005853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPKMixture, Hematology Quality Control

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 Date2016-09-21

On-Brand Devices [Hema-Trol]

00884883005860HYC84669
00884883005853HYC84668
00884883005846HYC84667
00884883005839HYC84666

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