Identity
- Trade Name
- Binax® Legionella EIA Wash Buffer Accessory Kit FDA UDI
- Generic Name
- Legionella pneumophila antigen IVD, reagent FDA UDI
- Device Name
- Wash Buffer intended for use only with Binax™ Legionella Urinary Antigen Enzyme Immunoassay kit. FDA UDI
- Model / Reference
- 851-100 FDA UDI
- Description
- Wash Buffer intended for use only with Binax™ Legionella Urinary Antigen Enzyme Immunoassay kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877010767 FDA UDI
- 510(k) Number
- K934965 FDA UDI
- FDA Product Code
- MJH FDA UDI
- GMDN Term
- Legionella pneumophila antigen IVD, reagent 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Legionella pneumophila antigen IVD, reagent
Binax® Legionella EIA Wash Buffer Accessory Kit 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, reagent.
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class II
Cleared under the same submission
K934965 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 7acf0310-b87e-4c50-bcca-cef2352beeaf 34 fields · synced May 30, 2026