The Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS-CoV-2 IgM assay for the in vitro qualitative detection of SARS-CoV-2 IgM antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgM calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.

The Access SARS
Access SARS-CoV-2 IgM Calibrator - C58958

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) 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

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

Device Id: 15099590738624

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