VITROS Immunodiagnostic Products Anti-SARS-COV-2 Total Controls

VITROS Immunodiagnostic Products Anti
VITROS - 6199924

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QKO

Device Name: Reagent, Coronavirus Serological

Device Class: N

Physical State: In vitro diagnostic device.

Definition: The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.

Submission Type ID: 8

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Serological assay.

Life Sustain Support Flag: N

Unclassified Reason: 11

Implant Flag: N

Target Area: Detection and differentiation of IgM and/or IgG antibodies from human specimens.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: QVP

Device Name: Sars-Cov-2 Serology Test

Device Class: 2

Physical State: Qualitative and quantitative assay for SARS-CoV-2 binding antibodies.

Definition: A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Detection of antibodies to SARS-CoV-2

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human blood specimen

Regulation Number: 866.3983

Third Party Flag: N

Medical Specialty: MI

Device Id: 10758750033409

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

Device Id: 20758750033406

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10758750033409

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case