Acucy Influenza A&B Control Kit

FDA UDI

Class II (US FDA UDI)

by Sekisui Diagnostics, LLC

Identity

Trade Name: Acucy Influenza A&B Control Kit FDA UDI
Generic Name: Influenza A/B virus antigen IVD, control FDA UDI
Model / Reference: 1011 FDA UDI

Identifiers

Primary DI / UDI-DI: 00742860100383 FDA UDI
FDA Product Code: PSZ FDA UDI
GMDN Term: Influenza A/B virus antigen IVD, control 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Influenza A/B virus antigen IVD, control

Acucy Influenza A&B Control Kit by Sekisui Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Sekisui Diagnostics, LLC

Sources (1)

FDA UDI 8bb4bed0-e691-44b7-9c8a-bf7a5b55189f 32 fields · synced Jun 9, 2026