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Nano-CheckTM Nicotine

FDA UDI

Class I (US FDA UDI)

by Nano-Ditech Corporation

Identity

Trade Name
Nano-CheckTM Nicotine FDA UDI
Generic Name
Cotinine (nicotine metabolite) IVD, reagent FDA UDI
Device Name
In Vitro Diagnostic Test kit for the detection of Cotinine in human urine FDA UDI
Model / Reference
AD6083 FDA UDI
Description
In Vitro Diagnostic Test kit for the detection of Cotinine in human urine FDA UDI

Identifiers

Catalog Number
AD6083 FDA UDI
Primary DI / UDI-DI
00895160002359 FDA UDI
FDA Product Code
MKU FDA UDI
GMDN Term
Cotinine (nicotine metabolite) IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3220 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: Cotinine (nicotine metabolite) IVD, reagent

Nano-CheckTM Nicotine by Nano-Ditech Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cotinine (nicotine metabolite) IVD, reagent.

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 793833f7-b362-4dea-a4bc-bf0ba44eae1d 36 fields · synced Jun 9, 2026