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Triage

FDA UDI

Class II (US FDA UDI)

by Quidel Cardiovascular Inc.

Identity

Trade Name
Triage FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Triage TOX Drug Screen (OUS) FDA UDI
Model / Reference
94400EU FDA UDI
Description
Triage TOX Drug Screen (OUS) FDA UDI

Identifiers

Catalog Number
94400EU FDA UDI
Primary DI / UDI-DI
30014613337904 FDA UDI
FDA Product Code
LAF FDA UDI
LDP FDA UDI
DKZ FDA UDI
DJG FDA UDI
LCM FDA UDI
LDJ FDA UDI
DIS FDA UDI
JXO FDA UDI
MLK FDA UDI
JXM FDA UDI
DJR FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3610 FDA UDI
862.3030 FDA UDI
862.3100 FDA UDI
862.3650 FDA UDI
862.3870 FDA UDI
862.3150 FDA UDI
862.3250 FDA UDI
862.3910 FDA UDI
862.3170 FDA UDI
862.3620 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Triage by Quidel Cardiovascular 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
Quidel Cardiovascular Inc.

Sources (1)

  • FDA UDI 022c9ac1-237a-49bb-a122-099656d0d0bc 36 fields · synced May 30, 2026