VITROS Immunodiagnostic Products Anti
VITROS - 6199974
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.
Environmental Conditions
- May be stored frozen, avoid repeated freeze-thaw cycles
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 20758750034557
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10758750034550
Package Quantity: 30
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 10758750034550
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
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