This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems.

This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems.
IgE CAL SET - IE2492

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 E (IgE) antibodies to one or multiple allergens and total immunoglobulin E (IgE total) antibodies in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

After reconstitution, the material is stable for 4 weeks at +2°C to +8°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: DGC

Device Name: Ige, 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: 05055273203912

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