Alinity m EBV CTRL Kit

Alinity m EBV CTRL Kit
Alinity m - 09N43-085

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Epstein-Barr virus (EBV) in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QLX

Device Name: Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

Device Class: 2

Physical State: In vitro diagnostic test

Definition: A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection instrumentation. The test is intended for use as an aid in the management of transplant patients with active viral infection or at risk for developing viral infections. The test results are intended to be interpreted by qualified healthcare professionals in conjunction with other relevant clinical and laboratory findings.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Quantitative Polymerase Chain Reaction

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Blood and blood derived specimens

Regulation Number: 866.3183

Third Party Flag: N

Medical Specialty: MI

Device Id: 00884999049499

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