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OSOM Ultra Flu A&B 25T Kit

FDA UDI

Class II (US FDA UDI)

by Sekisui Diagnostics, LLC

Identity

Trade Name
OSOM Ultra Flu A&B 25T Kit FDA UDI
Generic Name
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
OSOM Ultra Flu A&B 25T Kit FDA UDI
Model / Reference
1006 FDA UDI
Description
OSOM Ultra Flu A&B 25T Kit FDA UDI

Identifiers

Catalog Number
1006 FDA UDI
Primary DI / UDI-DI
00742860100222 FDA UDI
FDA Product Code
PSZ FDA UDI
GMDN Term
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3328 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: Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

OSOM Ultra Flu A&B 25T Kit by Sekisui Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Influenza A/B virus antigen IVD, kit, rapid ICT, clinical.

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 76c95a56-e0f7-4261-bb2e-80a6b756779a 35 fields · synced Jun 9, 2026