A rapid test for the qualitative detection of PBP2a in Staphylococcus aureus isolates.

A rapid test for the qualitative detection of PBP2a in Staphylococcus aureus isolates.
Alere™ PBP2a SA Culture Colony Test - 893-000

A collection of reagents and other associated materials intended to be used to determine the identification and antimicrobial susceptibility profile of bacterial species isolated from a clinical specimen by culture.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MYI

Device Name: System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 866.1640

Third Party Flag: Y

Medical Specialty: MI

Device Id: 10811877010842

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