Tina-quant Lipoprotein (a) Gen.2 Molarity

Basic Information

• Brand Name: Tina-quant Lipoprotein (a) Gen.2 Molarity
• Primary DI: 07613336237403
• Version / Model: 05852633160
• Catalog Number: 05852633160
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-27
• Public Version: 1
• Public Version Date: 2025-06-04
• Public Version Status: New
• Public Device Record Key: 29d11c96-ccac-4e3e-9940-62a46eb7f779

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
DFC	LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53438	Lipoprotein A IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613336237403	GS1

Premarket Submissions

Submission Number	Supplement Number
K241220	000