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Healgen (Private Label) - 264

FDA UDI

Class II (US FDA UDI)

by Confirm Biosciences LLC

Identity

Trade Name
Healgen (Private Label) - 264 FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
6 Panel Dip Card - CLIA - COC/AMP/mAMP/THC/OPI/BZO FDA UDI
Model / Reference
CB-HE-264 FDA UDI
Description
6 Panel Dip Card - CLIA - COC/AMP/mAMP/THC/OPI/BZO FDA UDI

Identifiers

Primary DI / UDI-DI
00895330002653 FDA UDI
FDA Product Code
JXM FDA UDI
DJG FDA UDI
DKE FDA UDI
DJC FDA UDI
DKZ FDA UDI
DIO FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3170 FDA UDI
862.3650 FDA UDI
862.3870 FDA UDI
862.3610 FDA UDI
862.3100 FDA UDI
862.3250 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

No

FDA UDI

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Healgen (Private Label) - 264 by Confirm Biosciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

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 f2413a2e-f6eb-47a2-8bb1-087d257ab157 33 fields · synced May 30, 2026