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Fluoro-CheckTM cTnI

FDA UDI

Class II (US FDA UDI)

by Nano-Ditech Corporation

Identity

Trade Name
Fluoro-CheckTM cTnI FDA UDI
Generic Name
Troponin I IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human while blood, serum and plasma of myocardial infarction patients FDA UDI
Model / Reference
TF3151 FDA UDI
Description
Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human while blood, serum and plasma of myocardial infarction patients FDA UDI

Identifiers

Catalog Number
TF3151 FDA UDI
Primary DI / UDI-DI
00895160002410 FDA UDI
FDA Product Code
MMI FDA UDI
GMDN Term
Troponin I IVD, kit, fluorescent immunoassay 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: Troponin I IVD, kit, fluorescent immunoassay

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

Similar devices

Also classified as Troponin I 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 6b7503ad-c20f-4517-86b9-1a04edb2ad4d 36 fields · synced Jun 9, 2026