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Sofia

FDA UDI

Class N (US FDA UDI)

by Quidel Corp.

Identity

Trade Name
Sofia FDA UDI
Generic Name
Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Sofia®2 Flu + SARS Antigen FIA FDA UDI
Model / Reference
20377 FDA UDI
Description
Sofia®2 Flu + SARS Antigen FIA FDA UDI

Identifiers

Catalog Number
20377 FDA UDI
Primary DI / UDI-DI
30014613339229 FDA UDI
FDA Product Code
QMN FDA UDI
GMDN Term
Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
N 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: Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

Sofia by Quidel Corp. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quidel Corp.

Sources (1)

  • FDA UDI 60930015-292b-4d8a-aa1f-885d0bc3be1b 35 fields · synced Jun 8, 2026