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BinaxNOW Legionella Urinary Antigen Card

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
BinaxNOW Legionella Urinary Antigen Card FDA UDI
Generic Name
Legionella pneumophila antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
The 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 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
10811877011023 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
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

No

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: Legionella pneumophila antigen IVD, kit, rapid ICT, clinical

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

Similar devices

Also classified as Legionella pneumophila antigen IVD, kit, rapid ICT, clinical.

Cleared under the same submission

K070522 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alere Scarborough, Inc.

Sources (1)

  • FDA UDI 04ea491b-2bce-4f2e-a4be-7ee2bce316bc 34 fields · synced Jun 8, 2026