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Nano-CheckTM AMI 2 in 1

FDA UDI

Class II (US FDA UDI)

by Nano-Ditech Corporation

Identity

Trade Name
Nano-CheckTM AMI 2 in 1 FDA UDI
Generic Name
Multiple cardiac marker IVD, reagent FDA UDI
Device Name
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human whole blood, serum and plasma FDA UDI
Model / Reference
CD202P FDA UDI
Description
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human whole blood, serum and plasma FDA UDI

Identifiers

Catalog Number
CD202P FDA UDI
Primary DI / UDI-DI
00895160002120 FDA UDI
FDA Product Code
DDR FDA UDI
MMI FDA UDI
GMDN Term
Multiple cardiac marker IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5680 FDA UDI
862.1215 FDA UDI
Commercial Distribution
Not 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

Nano-CheckTM AMI 2 in 1 by Nano-Ditech Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 bc25f1a5-c9a1-4da3-937e-00f60f70695e 37 fields · synced Jun 9, 2026