The product is intended for the quantitative in vitro determination of IgA in serum or plasma.

The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
IgA - IA7157

Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antibodies to Immunoglobulin A (anti-IgA) in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

On board the analyser the reagent is stable for 6 weeks at +10°C

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: CZP

Device Name: Iga, Antigen, Antiserum, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.5510

Third Party Flag: Y

Medical Specialty: IM

Device Identifiers

Device Id: 05055273203905

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