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Alere Triage®

FDA UDI

Class II (US FDA UDI)

by Alere San Diego, Inc.

Identity

Trade Name
Alere Triage® FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Alere Triage® Drugs of Abuse Panel Plus TCA FDA UDI
Model / Reference
92000 FDA UDI
Description
Alere Triage® Drugs of Abuse Panel Plus TCA FDA UDI

Identifiers

Catalog Number
92000 FDA UDI
Primary DI / UDI-DI
00893038002104 FDA UDI
FDA Product Code
MLK FDA UDI
DIS FDA UDI
DJG FDA UDI
LDJ FDA UDI
DKZ FDA UDI
DIO FDA UDI
JXM FDA UDI
LCM FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3910 FDA UDI
862.3150 FDA UDI
862.3650 FDA UDI
862.3870 FDA UDI
862.3100 FDA UDI
862.3250 FDA UDI
862.3170 FDA UDI
Commercial Distribution
Not 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

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

Yes

FDA UDI

Alere Triage® by Alere San Diego, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 9f6ec0d5-b5cf-44ec-847f-c45065d4e86f 37 fields · synced Jun 9, 2026