MedTest DX Lipoprotein (a) Calibrator for the BS480

Basic Information

• Brand Name: MedTest DX Lipoprotein (a) Calibrator for the BS480
• Primary DI: 00817439021090
• Version / Model: LPAC480
• Catalog Number: LPAC480
• Company Name: Medtest Dx, Inc.
• Labeler DUNS: 070371210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8590aaff-330a-4f5a-bf63-61b953de98fc

Device Description

Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calibration of Lipoprotein(a). 5 x 1 ml.

Device Characteristics

• Single Use: No
• 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: 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
53442	Lipoprotein A IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of lipoprotein A lipid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817439021090	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K013359	000

Storage Conditions

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