promega.comOncoMate MSI Dx Analysis System
Promega Corporation
Promega Corporation
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2134567 | 3002622561 | Promega Corporation | 1 | N | 2026-01-01 | 2800 Woods Hollow Road Madison WI US 53711 |
| 3009311010 | 3009311010 | Promega Biosystems Inc. | 1 | N | 2026-01-01 | #1017 A Building Gangseo-Hangang-Xi Tower 401 Yangcheon-ro, Gangseo-gu Seoul KR 07528 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00849811060960 | Maxwell® CSC Viral Total Nucleic Acid Purification Kit - The Maxwell® CSC Viral Total Nucleic Acid Purification DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of viral total nucleic acid from human samples. | 608-839-7919 | techserv@promega.com |
| 00849811066115 | Maxwell® CSC Genomic DNA Kit - The Maxwell® CSC Genomic DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of genomic DNA from human samples. | 608-839-7919 | techserv@promega.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 55727 | 1368805917 | P240026 | OncoMate® MSI Dx Analysis System | SFL | 2025-11-05 |
| 55727 | 1656214939 | K200129 | OncoMate MSI Dx Analysis System | PZJ | 2021-07-26 |
| 55727 | 1202306228 | ||||
| 55727 | 1072065726 | ||||
| 55727 | 1439628722 | ||||
| 183436 | 1439628722 | ||||
| 55727 | 1555013503 | ||||
| 55727 | 1571783742 | ||||
| 55727 | 1636038017 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PZJ | 1 | 2021-07-26 |
PMN#
GUDID#
Maxwell® CSC Rapid ccfDNA Kit - The Maxwell® CSC Rapid ccfDNA Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of circulating cell-free DNA from human plasma samples.
2026-02-16
OncoMate® MSI Dx Analysis Software - Software used to analyze data obtained using the OncoMate® MSI Dx Analysis System
2026-02-16
Maxwell® CSC XtractAll FFPE DNA/RNA Kit - The Maxwell® CSC XtractAll FFPE DNA/RNA Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of nucleic acid from human FFPE tissue samples.
2026-02-16
OncoMate® MSI Dx Assay Installer - Software for installing OncoMate® MSI Dx Analysis System assay method on the 3500Dx Genetic Analyzer
2026-02-16
OncoMate MSI Dx Analysis System - 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.
2021-09-30
OncoMate 5C Matrix Standard - Spectral calibration standard used with the Applied Biosystems® 3500 Dx Genetic Analyzer to generate a multicomponent matrix that is applied during the subsequent analysis of amplification products from the OncoMate™ MSI Dx Analysis System.
2021-09-30
Maxwell® CSC Genomic DNA Kit - The Maxwell® CSC Genomic DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of genomic DNA from human samples.
2023-06-12
Maxwell® CSC Viral Total Nucleic Acid Purification Kit - The Maxwell® CSC Viral Total Nucleic Acid Purification DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of viral total nucleic acid from human samples.
2022-02-01
Maxwell® CSC Whole Blood DNA Kit - The Maxwell® CSC Blood DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of genomic DNA from whole human blood samples.
2022-02-01
Maxwell® CSC Pathogen Total Nucleic Acid Kit - The Maxwell® CSC Pathogen Total Nucleic Acid DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of pathogen total nucleic acid from human samples.
2023-06-12
Maxwell® CSC Instrument - The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.
2022-02-01
Maxwell® CSC 48 Instrument - The Maxwell® CSC 48 Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.
2022-02-01
QuantiFluor® Dx dsDNA System - The QuantiFluor® Dx dsDNA System is a fluorescent dye-based test intended to quantify double-stranded DNA (dsDNA) in a sample containing purified nucleic acid.
2023-08-15
Maxwell® CSC RNA Blood Kit - The Maxwell® CSC RNA Blood Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of RNA from whole human blood samples.
2022-02-01
Maxwell® CSC RNA FFPE Kit - The Maxwell® CSC RNA FFPE kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of RNA from FFPE (formalin fixed, paraffin embedded) tissue samples.
2022-02-01
Maxwell® CSC DNA FFPE Kit - The Maxwell® CSC DNA FFPE Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of DNA from FFPE (formalin fixed, paraffin embedded) tissue samples.
2022-02-01
Maxwell® CSC Blood DNA Kit - The Maxwell® CSC Blood DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of genomic DNA from whole human blood samples.
2022-02-01
OncoMate MSI Dx Interpretive Software - Software used to interpret data obtained using the OncoMate MSI Dx Analysis System.
2021-10-08
OncoMate MSI Dx Assay Installer - Software for installing OncoMate MSI Dx Analysis System assay method on the 3500Dx Genetic Analyzer
2021-10-08
Abbott mSample Preparation System - Abbott mSample Preparation System is a nucleic acid extraction system used for laboratory isolation of RNA from biological samples.
2017-08-25
Abbott mSample Preparation System DNA - Abbott mSample Preparation System DNA is a nucleic acid extraction system used for laboratory isolation of DNA from biological samples.
2017-08-25
Abbott mSample Preparation System DBS Buffer Kit - Abbott mSample Preparation System DBS Buffer
2017-08-25
Abbott mSample Preparation System RNA Bulk Lysis Buffer Kit - Lysis buffer used to lyse cells for nucleic acid extraction.
2017-08-25