The Pre eclampsia Control Level 2 is intended for use with in vitro diagnostic assays for the quantitative determination of placental growth factor (PlGF) and soluble fms like tyrosine kinase 1 (sFlt 1) in human serum and plasma. The Pre eclampsia Control Level 2 is assayed with target values and are suitable for use on various analysers. The Pre eclampsia Control Level 2 is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
PRE-ECLAMPSIA CONTROL LEVEL 2 - PE10528
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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.
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: 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: 05055273219012
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