Tina-quant Apolipoprotein A-1 ver.2

Basic Information

• Brand Name: Tina-quant Apolipoprotein A-1 ver.2
• Primary DI: 07613336133521
• Version / Model: 08105448190
• Catalog Number: 08105448190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-16
• Public Version: 1
• Public Version Date: 2020-03-24
• Public Version Status: New
• Public Device Record Key: 87bcb20b-4f9c-4a71-bf0b-cb5d35f2506c

Device Characteristics

• Single Use: Yes
• 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
DER	ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53443	Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of apolipoprotein A-I (Apo A1) 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	07613336133521	GS1

Premarket Submissions

Submission Number	Supplement Number
K013249	000

Storage Conditions

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