The Revogene® Strep A assay, performed on the Revogene® instrument, is an automated, qualitative in vitro diagnostic test that utilizes real
Revogene® Strep A - 410400
Device Description
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).
Environmental Conditions
- 25.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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
Code: OOI
Device Name: Real Time Nucleic Acid Amplification System
Device Class: 2
Physical State: Should not include microarray or electrophoresis detection methods or instruments.
Definition: The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.2570
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00628055344179
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