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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 cardiac marker IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Triage Cardiac Panel (CK/TnI) FDA UDI
Model / Reference
97022HS FDA UDI
Description
Triage Cardiac Panel (CK/TnI) FDA UDI

Identifiers

Catalog Number
97022HS FDA UDI
Primary DI / UDI-DI
30014613337942 FDA UDI
FDA Product Code
MMI FDA UDI
JHX FDA UDI
GMDN Term
Multiple cardiac marker IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1215 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

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

Category: Multiple cardiac marker IVD, kit, fluorescent immunoassay

Triage by Quidel Cardiovascular Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple cardiac marker IVD, kit, fluorescent immunoassay.

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 a7b79960-8add-411e-9746-df7e7f4bf227 35 fields · synced Jun 8, 2026