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Alere iCup Dx Pro 2

FDA UDI

Class II (US FDA UDI)

by Instant Technologies, Inc.

Identity

Trade Name
Alere iCup Dx Pro 2 FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (COC/OPI300/AMP/OXY/BZO/THC) FDA UDI
Model / Reference
I-DXP-167-02 FDA UDI
Description
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (COC/OPI300/AMP/OXY/BZO/THC) FDA UDI

Identifiers

Catalog Number
I-DXP-167-02 FDA UDI
Primary DI / UDI-DI
00858945006812 FDA UDI
FDA Product Code
LDJ FDA UDI
JXM FDA UDI
DKZ FDA UDI
DJG FDA UDI
DIO 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
862.3170 FDA UDI
862.3100 FDA UDI
862.3650 FDA UDI
862.3250 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

Yes

FDA UDI

Convenience Kit

Yes

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

Alere iCup Dx Pro 2 by Instant Technologies, 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
Instant Technologies, Inc.

Sources (1)

  • FDA UDI 256a5a84-2160-4c76-b96b-0d623704b454 36 fields · synced May 29, 2026