← Back to catalogue

DrugConfirm

FDA UDI

Class II (US FDA UDI)

by Confirm Biosciences LLC

Identity

Trade Name
DrugConfirm FDA UDI
Generic Name
Cocaine/cocaine metabolite IVD, reagent FDA UDI
Device Name
4 Drugs Tested Home Drug Test FDA UDI
Model / Reference
CB-DC-4PanelOTC FDA UDI
Description
4 Drugs Tested Home Drug Test FDA UDI

Identifiers

Primary DI / UDI-DI
00856464008409 FDA UDI
FDA Product Code
NFY FDA UDI
NGG FDA UDI
NGL FDA UDI
NFW FDA UDI
GMDN Term
Cocaine/cocaine metabolite IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3250 FDA UDI
862.3610 FDA UDI
862.3650 FDA UDI
862.3870 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

Yes

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

No

FDA UDI

Category: Cannabinoid/cannabinoid metabolite IVD, reagentCocaine/cocaine metabolite IVD, reagentOpiate/opiate metabolite IVD, reagentMethamphetamine-specific IVD, reagent

DrugConfirm by Confirm Biosciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Methamphetamine-specific IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Confirm Biosciences LLC

Sources (1)

  • FDA UDI d746974b-8b7d-4165-bb2e-247518de49c5 33 fields · synced May 29, 2026