Alinity m CMV CAL Kit

Alinity m CMV CAL Kit
Alinity m - 09N46-075

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from cytomegalovirus (CMV) in a clinical specimen.

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: 3

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 or whole blood. 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: 2

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: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00884999049598

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