Troponin I (human Cardiac-Specific) Enzyme Immunoassay Test Kit

FDA UDI

Class II (US FDA UDI)

by Biomerica, Inc.

Identity

Trade Name: TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT FDA UDI
Generic Name: Troponin T/Troponin I IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI). FDA UDI
Model / Reference: 7031 FDA UDI
Description: The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI). FDA UDI

Identifiers

Primary DI / UDI-DI: 00083059070316 FDA UDI
510(k) Number: K013062 FDA UDI
FDA Product Code: MMI FDA UDI
GMDN Term: Troponin T/Troponin I IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1215 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: Troponin T/Troponin I IVD, kit, enzyme immunoassay (EIA)

Troponin I (human Cardiac-Specific) Enzyme Immunoassay Test Kit by Biomerica, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K013062 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 fa89896f-4b49-4c58-a953-a54d9eba4818 35 fields · synced May 31, 2026