MassARRAAY Dx

Basic Information

• Brand Name: MassARRAAY Dx
• Primary DI: 00850010566009
• Version / Model: 260050
• Catalog Number: 260050
• Company Name: AGENA BIOSCIENCE, INC.
• Labeler DUNS: 079436896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-08
• Public Version: 1
• Public Version Date: 2020-09-16
• Public Version Status: New
• Public Device Record Key: a965e988-d956-455f-a7fe-ca6a0dfaeb9f

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: Yes
• Has Manufacturing Date: Yes
• 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
DOP	MASS SPECTROMETER, CLINICAL USE	Clinical Chemistry	862.2860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57848	Mass spectrometry analyser IVD, automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative determination of the chemical composition of a clinical specimen by ionizing the specimen and separating the resulting ions according to mass using an electrical and magnetic field. The device operates with minimal technician involvement and complete automation of all procedural steps.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850010566009	GS1

Customer Contacts

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