← Back to catalogue

Binax® Legionella Urinary Antigen EIA

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
Binax® Legionella Urinary Antigen EIA FDA UDI
Generic Name
Legionella pneumophila antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
For the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine. FDA UDI
Model / Reference
851-000 FDA UDI
Description
For the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine. FDA UDI

Identifiers

Primary DI / UDI-DI
10811877010460 FDA UDI
510(k) Number
K934965 FDA UDI
FDA Product Code
MJH FDA UDI
GMDN Term
Legionella pneumophila antigen IVD, kit, enzyme immunoassay (EIA) 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, enzyme immunoassay (EIA)

Binax® Legionella Urinary Antigen EIA 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, enzyme immunoassay (EIA).

Cleared under the same submission

K934965 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alere Scarborough, Inc.

Sources (1)

  • FDA UDI 6d88293b-e714-46a7-a7ec-bc7de30bc3fd 34 fields · synced Jun 1, 2026