This product is intended for in vitro diagnostic use in the quality control of serum on clinical chemistry and immunoassay systems. The Assayed Liquid Protein Controls are for the control of accuracy.
SP CONTROL 2 - PS2683
Device Description
A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen.
Environmental Conditions
- Once opened Protein control material is stable for 30 days at +2°C to +8°C, if kept
- 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: JJY
Device Name: Multi-Analyte Controls, All Kinds (Assayed)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
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: 862.1660
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 05055273204902
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