Alere™ BinaxNOW® Legionella Urinary Antigen Card

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name: Alere™ BinaxNOW® Legionella Urinary Antigen Card FDA UDI
Generic Name: Legionella pneumophila antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name: The Alere BinaxNOW® Legionella Urinary Antigen Card is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in urine specimens from patients with symptoms of pneumonia. FDA UDI
Model / Reference: 852-000 FDA UDI
Description: The Alere BinaxNOW® Legionella Urinary Antigen Card is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in urine specimens from patients with symptoms of pneumonia. FDA UDI

Identifiers

Primary DI / UDI-DI: 10811877010477 FDA UDI
510(k) Number: K070522 FDA UDI
FDA Product Code: MJH FDA UDI
GMDN Term: Legionella pneumophila antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3300 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

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Manufacturing Date

FDA UDI

Alere™ BinaxNOW® Legionella Urinary Antigen Card by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K070522 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 II	Pending data

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Manufacturer

Manufacturer: Alere Scarborough, Inc.

Sources (1)

FDA UDI 2095aca7-d0ce-4f13-b4a6-9297a188c877 35 fields · synced Jun 6, 2026