Myoglobin Enzyme Immunoassay Test Kit

GUDID 08305900070309

The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum.

BIOMERICA, INC.

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Primary Device ID08305900070309
NIH Device Record Key09a807ab-03e9-4d8a-ad0e-9ae591db0caa
Commercial Distribution Discontinuation2020-07-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMyoglobin Enzyme Immunoassay Test Kit
Version Model Number7030
Company DUNS067647321
Company NameBIOMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Customer Support Contacts

Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108305900070309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRRAmplifier And Signal Conditioner, Biopotential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-02
Device Publish Date2016-12-07

On-Brand Devices [Myoglobin Enzyme Immunoassay Test Kit]

00083059070309The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum.
08305900070309The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum.
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