AdviseDx SARS-CoV-2 IgM Calibrator Kit

AdviseDx SARS
Alinity - 06R9101

Device Description

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.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

0.00
N/A

Special Storage Condition, Specify

store below -20 CEL until first use, Protect from light

Storage Environment Temperature - Degrees Celsius

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: 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 Identifiers

Device Id: 00380740192068

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