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Sofia

FDA UDI

Class I (US FDA UDI)

by Quidel Corp.

Identity

Trade Name
Sofia FDA UDI
Generic Name
Influenza A/B virus antigen IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Sofia Flu A+B 25T FDA UDI
Model / Reference
20218 FDA UDI
Description
Sofia Flu A+B 25T FDA UDI

Identifiers

Catalog Number
20218 FDA UDI
Primary DI / UDI-DI
30014613202189 FDA UDI
510(k) Number
K112177 FDA UDI
FDA Product Code
GNX FDA UDI
GMDN Term
Influenza A/B virus antigen IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3330 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

No

FDA UDI

Category: Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

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

Similar devices

Also classified as Influenza A/B virus antigen IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K112177 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 3a6881ea-9542-49ce-875e-d35d846a2cee 36 fields · synced May 30, 2026