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Fluoro-CheckTM D-Dimer

FDA UDI

Class II (US FDA UDI)

by Nano-Ditech Corporation

Identity

Trade Name
Fluoro-CheckTM D-Dimer FDA UDI
Generic Name
D-dimer IVD, kit, fluorescent immunoassay FDA UDI
Device Name
In Vitro Diagnostic Test kit for the evaluation of D-Dimer concentration in human whole blood and plasma FDA UDI
Model / Reference
TF3162 FDA UDI
Description
In Vitro Diagnostic Test kit for the evaluation of D-Dimer concentration in human whole blood and plasma FDA UDI

Identifiers

Catalog Number
TF3162 FDA UDI
Primary DI / UDI-DI
00895160002502 FDA UDI
FDA Product Code
DAP FDA UDI
GMDN Term
D-dimer IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7320 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: D-dimer IVD, kit, fluorescent immunoassay

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

Similar devices

Also classified as D-dimer 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 5a7a3d76-7ec7-4494-a82f-658370e2a24b 36 fields · synced Jun 9, 2026