BinaxNOW Nasopharyngeal Swab Accessory Kit

FDA UDI

Class I (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name: BinaxNOW Nasopharyngeal Swab Accessory Kit FDA UDI
Generic Name: General specimen collection kit IVD, clinical FDA UDI
Device Name: Nasopharyngeal Swabs intended for use only with products manufactured by Abbott Diagnostics Scarborough, Inc. FDA UDI
Model / Reference: 400-065 FDA UDI
Description: Nasopharyngeal Swabs intended for use only with products manufactured by Abbott Diagnostics Scarborough, Inc. FDA UDI

Identifiers

Primary DI / UDI-DI: 10811877010484 FDA UDI
510(k) Number: K032166 FDA UDI
FDA Product Code: GQG FDA UDI
GMDN Term: General specimen collection kit IVD, clinical FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.3480 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: General specimen collection kit IVD, clinical

BinaxNOW Nasopharyngeal Swab Accessory Kit by Alere Scarborough, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K032166 also covers:

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 I	Pending data

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Manufacturer

Manufacturer: Alere Scarborough, Inc.

Sources (1)

FDA UDI d678d619-b68d-419e-adbb-3c2c8b75917d 34 fields · synced Jun 8, 2026