OncoMate MSI Dx Analysis System MD2140

GUDID 00849811031717

Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections.

PROMEGA CORPORATION

Microsatellite instability IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00849811031717
• NIH Device Record Key: d0254d6d-f24c-4772-9fc5-f0cf60add546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OncoMate MSI Dx Analysis System
• Version Model Number: MD2140
• Catalog Number: MD2140
• Company DUNS: 089855696
• Company Name: PROMEGA CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849811031717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200129

FDA Product Code

• PZJ: Lynch Syndrome Test System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-08
• Device Publish Date: 2021-09-30

Devices Manufactured by PROMEGA CORPORATION

• 00849811075902 - QuantiFluor® Dx dsDNA System: 2023-08-23 The QuantiFluor® Dx dsDNA System is a fluorescent dye-based test intended to quantify double-stranded DNA (dsDNA) in a sample c
• 00849811066115 - Maxwell® CSC Genomic DNA Kit: 2023-06-20 The Maxwell® CSC Genomic DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isola
• 00849811069062 - Maxwell® CSC Pathogen Total Nucleic Acid Kit: 2023-06-20 The Maxwell® CSC Pathogen Total Nucleic Acid DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to per
• 00849811051340 - Maxwell® CSC Instrument: 2022-02-09 The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perf
• 00849811051739 - Maxwell® CSC RNA Blood Kit: 2022-02-09 The Maxwell® CSC RNA Blood Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolati
• 00849811051746 - Maxwell® CSC RNA FFPE Kit: 2022-02-09 The Maxwell® CSC RNA FFPE kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolatio
• 00849811051753 - Maxwell® CSC DNA FFPE Kit: 2022-02-09 The Maxwell® CSC DNA FFPE Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolatio
• 00849811051777 - Maxwell® CSC Blood DNA Kit: 2022-02-09 The Maxwell® CSC Blood DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolati