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Origin Instant Oral Drug Test

FDA UDI

Class II (US FDA UDI)

by Origin Diagnostics Llc

Identity

Trade Name
Origin Instant Oral Drug Test FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Origin Instant Oral Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-OPI-OXY-THC FDA UDI
Model / Reference
81025-OD-EI FDA UDI
Description
Origin Instant Oral Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-OPI-OXY-THC FDA UDI

Identifiers

Catalog Number
81025-OD-EI FDA UDI
Primary DI / UDI-DI
B77881025ODEI0 FDA UDI
FDA Product Code
PVJ FDA UDI
PVD FDA UDI
PVA FDA UDI
PUZ FDA UDI
PVH FDA UDI
PUY FDA UDI
PUX 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
862.3170 FDA UDI
862.3650 FDA UDI
862.3150 FDA UDI
862.3100 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

Origin Instant Oral Drug Test by Origin Diagnostics 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

Sources (1)

  • FDA UDI 70947f7f-4beb-4efc-b706-6887c4ccaa84 36 fields · synced May 30, 2026