PRE-ECLAMPSIA CONTROL LEVEL 3

Basic Information

• Brand Name: PRE-ECLAMPSIA CONTROL LEVEL 3
• Primary DI: 05055273218992
• Version / Model: PE10529
• Catalog Number: PE10529
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-21
• Public Version: 1
• Public Version Date: 2023-12-29
• Public Version Status: New
• Public Device Record Key: be80307c-43a3-4af3-8c22-d36dfe63c9cf

Device Description

The Pre eclampsia Control Level 3 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 3 is assayed with target values and are suitable for use on various analysers. The Pre eclampsia Control Level 3 is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47869	Multiple-type clinical chemistry analyte profile IVD, control	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273218992	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius