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Healgen (Private Label) - 242

FDA UDI

Class II (US FDA UDI)

by Confirm Biosciences LLC

Identity

Trade Name
Healgen (Private Label) - 242 FDA UDI
Generic Name
Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Healgen (DrugConfirm) - 4 panel Cup AMP1000/COC300/MET1000/OPI2000 FDA UDI
Model / Reference
CB-HE-CUP-242 FDA UDI
Description
Healgen (DrugConfirm) - 4 panel Cup AMP1000/COC300/MET1000/OPI2000 FDA UDI

Identifiers

Primary DI / UDI-DI
00856464008348 FDA UDI
FDA Product Code
NFT FDA UDI
NFY FDA UDI
NGG FDA UDI
NGL FDA UDI
GMDN Term
Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3100 FDA UDI
862.3250 FDA UDI
862.3610 FDA UDI
862.3650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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: Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinicalCocaine/cocaine metabolite IVD, reagentOpiate/opiate metabolite IVD, reagentMethamphetamine-specific IVD, reagent

Healgen (Private Label) - 242 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

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Manufacturer

Manufacturer
Confirm Biosciences LLC

Sources (1)

  • FDA UDI ffad69bf-f91a-41ea-a436-4070a6934437 33 fields · synced Jun 1, 2026