← Back to catalogue

CERTUM One Step Multi-Drug Screen Panel

FDA UDI

Class II (US FDA UDI)

by Alere San Diego, Inc.

Identity

Trade Name
CERTUM One Step Multi-Drug Screen Panel FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
COC300/AMP1000/THC50 FDA UDI
Model / Reference
DOA-134-011-a FDA UDI
Description
COC300/AMP1000/THC50 FDA UDI

Identifiers

Catalog Number
4566621326 FDA UDI
Primary DI / UDI-DI
00810124273866 FDA UDI
FDA Product Code
DIO FDA UDI
DKZ FDA UDI
LDJ FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3250 FDA UDI
862.3100 FDA UDI
862.3870 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

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, kit, rapid ICT, clinical

CERTUM One Step Multi-Drug Screen Panel by Alere San Diego, 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alere San Diego, Inc.

Sources (1)

  • FDA UDI b615b15b-9cab-40dc-9d39-26868e4d18b7 34 fields · synced Jun 9, 2026