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Nano-CheckTM AMI CK-MB

FDA UDI

Class II (US FDA UDI)

by Nano-Ditech Corporation

Identity

Trade Name
Nano-CheckTM AMI CK-MB FDA UDI
Generic Name
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical FDA UDI
Device Name
In Vitro Diagnostic Test kit for the detection of Creatine kinase MB in human whole blood, serum and plasma FDA UDI
Model / Reference
CD7142 FDA UDI
Description
In Vitro Diagnostic Test kit for the detection of Creatine kinase MB in human whole blood, serum and plasma FDA UDI

Identifiers

Catalog Number
CD7142 FDA UDI
Primary DI / UDI-DI
00895160002021 FDA UDI
FDA Product Code
JHT FDA UDI
GMDN Term
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical 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

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: Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical

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

Similar devices

Also classified as Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical.

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 a22418ca-a538-4a98-a5ef-ca3570b6e14c 36 fields · synced Jun 9, 2026