OncoMate MSI Dx Interpretive Software

Basic Information

• Brand Name: OncoMate MSI Dx Interpretive Software
• Primary DI: 00849811056857
• Version / Model: MD4140
• Catalog Number: MD4140
• Company Name: PROMEGA CORPORATION
• Labeler DUNS: 089855696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-08
• Public Version: 1
• Public Version Date: 2021-10-18
• Public Version Status: New
• Public Device Record Key: 887f41bc-636d-4410-a0c8-eaea0fab0071

Device Description

Software used to interpret data obtained using the OncoMate MSI Dx Analysis System.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
PZJ	Lynch Syndrome Test System	Immunology	864.1866	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60202	Microsatellite instability IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for determining microsatellite instability [abnormal repeated sequences of deoxyribonucleic acid (DNA)] within a tumour tissue specimen, using a nucleic acid technique (NAT). This phenomenon which is associated with defective DNA mismatch repair genes is a feature of certain cancer types including hereditary nonpolyposis colon cancer (HNPCC).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849811056857	GS1

Premarket Submissions

Submission Number	Supplement Number
K200129	000