Control swabs intended for use only with Legionella product manufactured by Alere Scarborough, Inc.

Control swabs intended for use only with Legionella product manufactured by Alere Scarborough, Inc.
Alere™ BinaxNOW® Legionella Control Swab Kit - 852-010

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple serogroups of Legionella pneumophila bacteria in a clinical specimen.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MJH

Device Name: Legionella, Spp., Elisa

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3300

Third Party Flag: N

Medical Specialty: MI

Device Id: 10811877010491

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A