Myoglobin Enzyme Immunoassay Test Kit - The Myoglobin ELISA is intended for the - BIOMERICA, INC.

Duns Number:067647321

Device Description: The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human s The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum.

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More Product Details

Catalog Number

-

Brand Name

Myoglobin Enzyme Immunoassay Test Kit

Version/Model Number

7030

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K022660

Product Code Details

Product Code

DRR

Product Code Name

Amplifier And Signal Conditioner, Biopotential

Device Record Status

Public Device Record Key

09a807ab-03e9-4d8a-ad0e-9ae591db0caa

Public Version Date

September 02, 2021

Public Version Number

4

DI Record Publish Date

December 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 35