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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
13 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC150-MDMA-MET-MTD-OPI300-OXY-PCP-PPX-THC FDA UDI
Model / Reference
61306 FDA UDI
Description
13 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC150-MDMA-MET-MTD-OPI300-OXY-PCP-PPX-THC FDA UDI

Identifiers

Catalog Number
61306 FDA UDI
Primary DI / UDI-DI
B298613060 FDA UDI
FDA Product Code
DJR FDA UDI
LAF FDA UDI
DIO FDA UDI
JXM FDA UDI
DJG FDA UDI
DIS FDA UDI
DKZ FDA UDI
LDJ FDA UDI
JXN FDA UDI
LCM FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3620 FDA UDI
862.3610 FDA UDI
862.3250 FDA UDI
862.3170 FDA UDI
862.3650 FDA UDI
862.3150 FDA UDI
862.3100 FDA UDI
862.3870 FDA UDI
862.3700 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

Manufacturer
Express Diagnostics Int'l, Inc.

Sources (1)

  • FDA UDI ba67492d-03b0-43a9-a7d5-a288dd9bb406 37 fields · synced Jun 8, 2026