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OSOM Flu SARS-CoV-2 Combo Home

FDA UDI

Class N (US FDA UDI)

by Sekisui Diagnostics, LLC

Identity

Trade Name
OSOM Flu SARS-CoV-2 Combo Home FDA UDI
Generic Name
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing FDA UDI
Device Name
OSOM Flu SARS-CoV-2 Combo Home FDA UDI
Model / Reference
1074 FDA UDI
Description
OSOM Flu SARS-CoV-2 Combo Home FDA UDI

Identifiers

Catalog Number
1074 FDA UDI
Primary DI / UDI-DI
00742860000089 FDA UDI
FDA Product Code
QKP FDA UDI
GMDN Term
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing 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

No

FDA UDI

Over-the-Counter

Yes

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, rapid ICT, self-testing

OSOM Flu SARS-CoV-2 Combo Home by Sekisui Diagnostics, LLC — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sekisui Diagnostics, LLC

Sources (1)

  • FDA UDI d58633c3-ced3-46cd-b5c3-4b60aa28fa58 34 fields · synced Jun 9, 2026