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NicCheck I

FDA UDI

Class I (US FDA UDI)

by Mossman Associates, Inc.

Identity

Trade Name
NicCheck I FDA UDI
Generic Name
Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
rapid urine test for the semi-quantitative measurement of nicotine and nicotine metabolites FDA UDI
Model / Reference
1 FDA UDI
Description
rapid urine test for the semi-quantitative measurement of nicotine and nicotine metabolites FDA UDI

Identifiers

Catalog Number
500-001 FDA UDI
Primary DI / UDI-DI
00860007588907 FDA UDI
510(k) Number
K963733 FDA UDI
FDA Product Code
MRS FDA UDI
GMDN Term
Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical

NicCheck I by Mossman Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mossman Associates, Inc.

Sources (1)

  • FDA UDI e74758bd-9c3f-4a9d-acc0-a1b5904acf92 36 fields · synced May 30, 2026