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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Myoglobin Enzyme Immunoassay Test Kit

Version/Model Number

7030

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

7f2c42c4-b871-462d-8fc2-116e10630f13

Public Version Date

July 09, 2020

Public Version Number

1

DI Record Publish Date

July 01, 2020

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