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DrugCheck

FDA UDI

Class II (US FDA UDI)

by Express Diagnostic Int'l, Inc.

Identity

Trade Name
DrugCheck FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
DrugCheck SalivaScan Oral Fluid Drug Test, AMP-COC-MET-OPI FDA UDI
Model / Reference
80410-EI FDA UDI
Description
DrugCheck SalivaScan Oral Fluid Drug Test, AMP-COC-MET-OPI FDA UDI

Identifiers

Catalog Number
80410-EI FDA UDI
Primary DI / UDI-DI
B29880410EI0 FDA UDI
FDA Product Code
PUX FDA UDI
PVA FDA UDI
PVD FDA UDI
PVH FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

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

Clinical & Handling

Sterile

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

Yes

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

DrugCheck by Express Diagnostic Int'l, Inc. — 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
Express Diagnostic Int'l, Inc.

Sources (1)

  • FDA UDI 0b38b4ac-c1a0-42f9-a03b-e44f4220510a 35 fields · synced Jun 1, 2026