MASTALEX-MRSA Rapid latex test for the detection of M.R.S.A.

MASTALEX
MASTALEX-MRSA - RST501

A collection of reagents and other associated materials intended to be used for the identification of Staphylococcus aureus bacteria isolated from a clinical specimen by culture, and for determining susceptibility of Staphylococcus aureus isolates to the antimicrobial methicillin, to identify methicillin-resistant Staphylococcus aureus (MRSA).

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: 15060392372705

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