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CERTUM One Step Multi-Line Drug Screen EZ Split

FDA UDI

Class II (US FDA UDI)

by Alere San Diego, Inc.

Identity

Trade Name
CERTUM One Step Multi-Line Drug Screen EZ Split FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
<COC300>+<AMP1000>+< mAMP1000>+<THC50>+<BAR300> +<BZO300> FDA UDI
Model / Reference
DBO-167-301-a FDA UDI
Description
<COC300>+<AMP1000>+< mAMP1000>+<THC50>+<BAR300> +<BZO300> FDA UDI

Identifiers

Catalog Number
4566571326 FDA UDI
Primary DI / UDI-DI
00810124273811 FDA UDI
FDA Product Code
DIO FDA UDI
DKZ FDA UDI
LDJ FDA UDI
DIS FDA UDI
JXM FDA UDI
DJC 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
862.3150 FDA UDI
862.3170 FDA UDI
862.3610 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-Line Drug Screen EZ Split 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

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Manufacturer

Manufacturer
Alere San Diego, Inc.

Sources (1)

  • FDA UDI f4342810-97e5-4dd1-a06b-970e7e4f67a2 34 fields · synced Jun 9, 2026