Alinity m HIV-1 Application Specification File

Alinity m HIV
Alinity m - 2.00

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: QST

Device Name: Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

Device Class: 2

Physical State: Lateral flow, membrane, manual, automated reader, swab, lancet, capillary, NAT, automated instrument

Definition: Human immunodeficiency virus (HIV) lab-based nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: PCR, amplification, extraction, buffers, purification, nucleic acid

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Whole blood, plasma, serum, oral fluid, capillary blood, venous blood

Regulation Number: 866.3957

Third Party Flag: N

Medical Specialty: MI

Code: MZF

Device Name: Test, Hiv Detection

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3956

Third Party Flag: N

Medical Specialty: MI

Device Id: 00884999050402

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