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

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