MAGPIX® Drive Fluid

Basic Information

• Brand Name: MAGPIX® Drive Fluid
• Primary DI: 00840487101421
• Version / Model: MPXDF-4PK-1
• Company Name: LUMINEX CORPORATION
• Labeler DUNS: 965476641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 4
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 1544b2cd-de2e-4e8d-a311-e7eeb6209806

Device Description

The MAGPIX Drive Fluid serves as the delivery medium that carries the sample to the optics component of the MAGPIX instrument.

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
NSU	Instrumentation for clinical multiplex test systems	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56727	Multiplex analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840487101421	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121894	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius