Simplexa™ Group A Strep Direct

Simplexa™ Group A Strep Direct - MOL2850

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nucleic acid technique (NAT).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PGX

Device Name: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Device Class: 2

Physical State: May include automated/manual isothermal nucleic acid amplification, polymerase chain reaction, ligase chain reaction, sequence-based amplification

Definition: An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses nucleic acid amplification technology to detect Groups A, C and G Sreptococci

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Throat swab specimen

Regulation Number: 866.2680

Third Party Flag: N

Medical Specialty: MI

Device Id: 20816101025569

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