VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator

VITROS Immunodiagnostic Products SARS
VITROS - 6199950

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a chemiluminescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QKP

Device Name: Coronavirus Antigen Detection Test System.

Device Class: N

Physical State: In vitro diagnostic device

Definition: The qualitative detection of coronavirus viral antigens directly from clinical specimens.

Submission Type ID: 8

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Antigen detection

Life Sustain Support Flag: N

Unclassified Reason: 11

Implant Flag: N

Target Area: Clinical specimens.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 10758750033591

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