MassARRAY Clean Resin 28g

Basic Information

• Brand Name: MassARRAY Clean Resin 28g
• Primary DI: 00850010566054
• Version / Model: 8040
• Catalog Number: 8040
• 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: 3498d8c9-9982-468d-8ade-033fdf82ca30

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
61323	Post-PCR cleanup kit IVD	A collection of reagents and other associated materials intended to be used for the purification of polymerase chain reaction (PCR) processed clinical specimens prior to downstream nucleic acid analysis. The kit typically consists of various buffer and/or washing solutions and can be used with manual or automated instruments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850010566054	GS1

Customer Contacts

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