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Fluoro-CheckTM AMI 3 in 1

FDA UDI

Class II (US FDA UDI)

by Nano-Ditech Corporation

Identity

Trade Name
Fluoro-CheckTM AMI 3 in 1 FDA UDI
Generic Name
Multiple cardiac marker IVD, kit, fluorescent immunoassay FDA UDI
Device Name
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma FDA UDI
Model / Reference
TF3154 FDA UDI
Description
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma FDA UDI

Identifiers

Catalog Number
TF3154 FDA UDI
Primary DI / UDI-DI
00895160002496 FDA UDI
FDA Product Code
MMI FDA UDI
DDR FDA UDI
JHT FDA UDI
GMDN Term
Multiple cardiac marker IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1215 FDA UDI
866.5680 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple cardiac marker IVD, kit, fluorescent immunoassay

Fluoro-CheckTM AMI 3 in 1 by Nano-Ditech Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple cardiac marker IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nano-Ditech Corporation

Sources (1)

  • FDA UDI 84d4197f-0af9-4868-9802-16b03495cdd8 36 fields · synced Jun 9, 2026