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SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup

FDA UDI

Class II (US FDA UDI)

by Alere San Diego, Inc.

Identity

Trade Name
SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
<COC300>+<AMP1000>+<THC50> FDA UDI
Model / Reference
DBO-137-071 FDA UDI
Description
<COC300>+<AMP1000>+<THC50> FDA UDI

Identifiers

Catalog Number
4566329019 FDA UDI
Primary DI / UDI-DI
00810124273569 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

Yes

FDA UDI

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup 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 9d236966-d482-47d2-8a6a-3907cae52568 34 fields · synced Jun 9, 2026