Platelia SARS-CoV-2 Total Ab

Platelia SARS
Platelia - 12015253

A collection of reagents and other associated materials 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 coronavirus disease (COVID-19), in a clinical specimen, using an enzyme immunoassay (EIA) method.

• 480 tests

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: 03610522220526

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