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Triage

FDA UDI

Class II (US FDA UDI)

by Quidel Cardiovascular Inc.

Identity

Trade Name
Triage FDA UDI
Generic Name
Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
Device Name
Quidel Triage MeterPro FDA UDI
Model / Reference
55070 FDA UDI
Description
Quidel Triage MeterPro FDA UDI

Identifiers

Catalog Number
55070 FDA UDI
Primary DI / UDI-DI
30014613337157 FDA UDI
FDA Product Code
MMI FDA UDI
JHX FDA UDI
DDR FDA UDI
KHO FDA UDI
GMDN Term
Fluorescent immunoassay analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1215 FDA UDI
866.5680 FDA UDI
862.2560 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Fluorescent immunoassay analyser IVD, point-of-care

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

Similar devices

Also classified as Fluorescent immunoassay analyser IVD, point-of-care.

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 86c54ec1-5096-42f2-b8d1-f56075ce3346 35 fields · synced May 30, 2026