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Detectabuse

FDA UDI

Class I (US FDA UDI)

by Biochemical Diagnostics Inc

Identity

Trade Name
DETECTABUSE FDA UDI
Generic Name
Multiple drugs of abuse IVD, control FDA UDI
Device Name
Menu CA Cutoff -50%, 50mL FDA UDI
Model / Reference
18008463 FDA UDI
Description
Menu CA Cutoff -50%, 50mL FDA UDI

Identifiers

Catalog Number
18008463 FDA UDI
Primary DI / UDI-DI
00810042683334 FDA UDI
FDA Product Code
DIF FDA UDI
GMDN Term
Multiple drugs of abuse IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3280 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Category: Multiple drugs of abuse IVD, control

Detectabuse by Biochemical Diagnostics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple drugs of abuse IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 7c981b14-5530-4c0f-9c9c-2e012f803425 36 fields · synced Jun 8, 2026