Alinity m CMV Application Specification File

Alinity m CMV Application Specification File
Alinity m - 09N46-05A

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).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PAB

Device Name: Cytomegalovirus (Cmv) Dna Quantitative Assay

Device Class: 2

Physical State: IVD

Definition: Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: In vitro nucleic acid based assay using real-time PCR for the quantitative measurement of CMV DNA

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not Applicable

Regulation Number: 866.3180

Third Party Flag: N

Medical Specialty: MI

Device Id: 00884999049956

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