← Back to catalogue

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 (10 Panel) FDA UDI
Model / Reference
94401 FDA UDI
Description
Triage TOX Drug Screen (10 Panel) FDA UDI

Identifiers

Catalog Number
94401 FDA UDI
Primary DI / UDI-DI
30014613337874 FDA UDI
FDA Product Code
MLK FDA UDI
LCM FDA UDI
DKZ FDA UDI
DJR FDA UDI
LAF FDA UDI
DIS FDA UDI
LDJ FDA UDI
JXM FDA UDI
DJG FDA UDI
JXO FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, fluorescent immunoassay FDA UDI

Classification

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Quidel Cardiovascular Inc.

Sources (1)

  • FDA UDI 3f8130fb-1950-4fc2-a1d2-528dc15b7a50 36 fields · synced May 30, 2026