ID NOW Influenza A & B Control Swab Kit

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name: ID NOW Influenza A & B Control Swab Kit FDA UDI
Generic Name: Influenza A/B virus nucleic acid IVD, control FDA UDI
Device Name: Control Swabs intended for use only with the ID NOW Influenza A & B product. FDA UDI
Model / Reference: 425-080 FDA UDI
Description: Control Swabs intended for use only with the ID NOW Influenza A & B product. FDA UDI

Identifiers

Primary DI / UDI-DI: 10811877010439 FDA UDI
510(k) Number: K171792 FDA UDI
FDA Product Code: OCC FDA UDI
OZE FDA UDI
PSZ FDA UDI
GMDN Term: Influenza A/B virus nucleic acid IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3980 FDA UDI
866.3328 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

ID NOW Influenza A & B Control Swab Kit by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K171792 also covers:

ID NOW Influenza A & B 2 Control Swab Kit — Alere Scarborough, Inc.

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: Alere Scarborough, Inc.

Sources (1)

FDA UDI fafdb009-bcdf-41b2-91c5-6e1abb519e7c 35 fields · synced May 30, 2026