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QuickVue

FDA UDI

Class II (US FDA UDI)

by Quidel Corp.

Identity

Trade Name
QuickVue FDA UDI
Generic Name
Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical FDA UDI
Device Name
QkVue hCG Urine 25T FDA UDI
Model / Reference
One-Step hCG Urine Test FDA UDI
Description
QkVue hCG Urine 25T FDA UDI

Identifiers

Catalog Number
20109 FDA UDI
Primary DI / UDI-DI
30014613201090 FDA UDI
510(k) Number
K020799 FDA UDI
FDA Product Code
JHI FDA UDI
GMDN Term
Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1155 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical

QuickVue by Quidel Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quidel Corp.

Sources (1)

  • FDA UDI 34edd9de-cfc6-4258-b904-914030a1fb44 36 fields · synced Jun 8, 2026