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DrugCheck

FDA UDI

Class II (US FDA UDI)

by Express Diagnostics Int'l, Inc.

Identity

Trade Name
DrugCheck FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
4 Panel Cup Drug Test, AMP-COC-MET-THC FDA UDI
Model / Reference
60430 FDA UDI
Description
4 Panel Cup Drug Test, AMP-COC-MET-THC FDA UDI

Identifiers

Catalog Number
60430 FDA UDI
Primary DI / UDI-DI
B298604300 FDA UDI
FDA Product Code
LDJ FDA UDI
LAF FDA UDI
DIO FDA UDI
DKZ FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3870 FDA UDI
862.3610 FDA UDI
862.3250 FDA UDI
862.3100 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

DrugCheck by Express Diagnostics Int'l, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI b1e7f22b-4a67-4ccc-b368-a9d49088f210 37 fields · synced May 31, 2026