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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 S/U, 30T FDA UDI
Model / Reference
hCG S/U Test FDA UDI
Description
QkVue+ hCG S/U, 30T FDA UDI

Identifiers

Catalog Number
00178 FDA UDI
Primary DI / UDI-DI
30014613001782 FDA UDI
510(k) Number
K973858 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.

Cleared under the same submission

K973858 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quidel Corp.

Sources (1)

  • FDA UDI cc285e8a-0d83-407e-adb7-70e12ff48782 36 fields · synced Jun 8, 2026