ADVIA Centaur IL6 Control - 10995083
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of interleukin-6 (IL-6) in a clinical specimen.
Environmental Conditions
- 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: QLC
Device Name: Interleukin 6
Device Class: N
Physical State: In Vitro Diagnostic Device
Definition: In vitro Diagnostic devices for the quantitative determination of IL-6 (interleukin 6) in human specimens
Submission Type ID: 8
Review Panel: IM
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Immunoassay
Life Sustain Support Flag: N
Unclassified Reason: 11
Implant Flag: N
Target Area: The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 00630414010472
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