Maxwell® CSC Instrument

Basic Information

• Brand Name: Maxwell® CSC Instrument
• Primary DI: 00849811051340
• Version / Model: AS6000
• Catalog Number: AS6000
• Company Name: PROMEGA CORPORATION
• Labeler DUNS: 089855696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-01
• Public Version: 1
• Public Version Date: 2022-02-09
• Public Version Status: New
• Public Device Record Key: 54d38f64-a761-4701-acec-137dff6fd091

Device Description

The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJH	Clinical Sample Concentrator	Clinical Chemistry	862.2310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60529	Magnetic particle separation instrument IVD, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the automated pre-analytical extraction of specific molecules from a clinical specimen using magnetic particle separation techniques. It is a software-controlled instrument that processes solutions using sequential immersion of magnetized rods, to attract labelled molecules, and rotation of demagnetized rods to create a new suspension/solution, and is typically used for nucleic acid isolation procedures. The device operates with reduced technician involvement and automation of some procedural steps.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849811051340	GS1

Customer Contacts

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