Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM, Version 1.0

Abbott RealTime HCV Genotype II m2000 System Combined Application CD
RealTime - 08L21-01

An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OBF

Device Name: Assay, Genotyping, Hepatitis C Virus

Device Class: 2

Physical State: RT-PCR amplification

Definition: In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human specimens

Regulation Number: 866.3170

Third Party Flag: N

Medical Specialty: MI

Device Id: 00884999034266

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