DIRECT HDL-CHOLESTEROL (HDL)

Basic Information

• Brand Name: DIRECT HDL-CHOLESTEROL (HDL)
• Primary DI: 05055273208412
• Version / Model: CH1383
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-04
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 049fe7b1-7c40-45f3-8901-b94c4d42e943

Device Description

Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in human serum and plasma.

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
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	862.1475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53391	High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273208412	GS1

Customer Contacts

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

Storage Conditions

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