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Healgen

FDA UDI

Class U (US FDA UDI)

by Healgen Scientific Limited Liability Company

Identity

Trade Name
Healgen FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
12 Panel DOA Test Dipcard FDA UDI
Model / Reference
HDOA-3124 FDA UDI
Description
12 Panel DOA Test Dipcard FDA UDI

Identifiers

Catalog Number
HDOA-3124 FDA UDI
Primary DI / UDI-DI
00816490021551 FDA UDI
FDA Product Code
LCM FDA UDI
DIS FDA UDI
JXM FDA UDI
DJG FDA UDI
LAF FDA UDI
DIO FDA UDI
LDJ FDA UDI
DKZ FDA UDI
LFG FDA UDI
DJR FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
862.3150 FDA UDI
862.3170 FDA UDI
862.3650 FDA UDI
862.3610 FDA UDI
862.3250 FDA UDI
862.3870 FDA UDI
862.3100 FDA UDI
862.3910 FDA UDI
862.3620 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

Yes

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

Healgen by Healgen Scientific Limited Liability Company — Class U — 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
Healgen Scientific Limited Liability Company

Sources (1)

  • FDA UDI a9dfc361-f315-4cb9-8d8f-9169943ce47c 36 fields · synced May 30, 2026