Myoglobin Enzyme Immunoassay Test Kit

FDA UDI

Class II (US FDA UDI)

by Biomerica, Inc.

Identity

Trade Name: Myoglobin Enzyme Immunoassay Test Kit FDA UDI
Generic Name: Myoglobin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum. FDA UDI
Model / Reference: 7030 FDA UDI
Description: The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum. FDA UDI

Identifiers

Primary DI / UDI-DI: 00083059070309 FDA UDI
510(k) Number: K022660 FDA UDI
FDA Product Code: DRR FDA UDI
GMDN Term: Myoglobin IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Myoglobin IVD, kit, enzyme immunoassay (EIA)

Myoglobin Enzyme Immunoassay Test Kit by Biomerica, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Myoglobin IVD, kit, enzyme immunoassay (EIA).

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Cleared under the same submission

K022660 also covers:

Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biomerica, Inc.

Sources (1)

FDA UDI 7f2c42c4-b871-462d-8fc2-116e10630f13 35 fields · synced May 29, 2026