Promega Corporation

FDA Device Registration & Listing · Madison, WI, US · Registration 2134567

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2134567
FEI Number
3002622561
Entity Name
Promega Corporation
City/State/Country
Madison, WI, US
Establishment Address
2800 Woods Hollow Road, Madison, WI 53711, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Promega Corporation (Owner Number: 9036108)
Owner / Operator Contact Address
2800 Woods Hollow Road, --, Madison, WI 53711, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OncoMate MSI Dx Interpretive Software OncoMate 5C Matrix Standard OncoMate MSI Dx Analysis System OncoMate MSI Dx Assay Installer OncoMate® MSI Dx Analysis System OncoMate® MSI Dx Analysis Software OncoMate® MSI Dx Assay Installer OncoMate®5C Matrix Standard QuantiFluor Dx dsDNA System Deoxynucleotide Triphosphates, 100mM rCTP (100mM) 5X PCR Buffer C BenchTop 100bp DNA Ladder PCR Nucleotide Mix, 10mM Reverse Transcription 10X Buffer T4 DNA Ligase (HC) Alcohol Wash, Blood dCTP, 100mM rATP, rCTP, rGTP, rUTP each at 10mM 5X PCR Buffer G Lambda DNA / Hind III Markers PhiX174 DNA / Hae III Markers 5X PCR Buffer A Anti-Foam Reagent PCR Marker Streptavidin MagneSphere Paramagnetic Particles 5X PCR Buffer E Lambda DNA / EcoR I + Hind III Markers 5X Green GoTaq Flexi Reaction Buffer Human Genomic DNA M-MLV Reverse Transcriptase Buffer Pack Seq Grade Modified Trypsin, Bulk Sale Size 5X Colorless GoTaq Flexi Reaction Buffer GoTaq Probe 1-Step RT-qPCR System Magnesium Chloride Solution, 25mM 5X Colorless GoTaq Reaction Buffer Herring Sperm DNA M-MLV Reverse Transcriptase GoTaq G2 Colorless Master Mix Human Genomic DNA: Male rUTP, 10mM 5X Green GoTaq Reaction Buffer AMV Reverse Transcriptase (HC) Human Genomic DNA: Female Nuclease-Free Water Set of dUTP, dCTP, dGTP, dATP 100mM each 200bp DNA Step Ladder DTT, 100mM GoTaq MDx Taq Polymerase GoTaq G2 DNA Polymerase ImProm-II Reverse Transcriptase dGTP, 100mM rCTP, 10mM 100bp DNA Step Ladder BenchTop PCR Markers PCR Optimization Kit rGTP, 10mM XpressAmp Direct Amp. Reagents GoTaq Flexi DNA Polymerase rUTP, 100mM 5X PCR Buffer B BCIP/NBT Color Development Substrate PCR Master Mix (2X) T4 DNA Ligase cAMP GoScript MDx Reverse Transcriptase RNasin Plus RNase Inhibitor 1kb DNA Step Ladder BenchTop PhiX174 DNA/Hae III Markers dUTP, 100mM RNase ONE Ribonuclease dNTP Mix, 10mM GoTaq MDx Hot Start Polymerase, Glycerol-Free 5X PCR Buffer D GoTaq G2 Green Master Mix Lambda DNA 5X PCR Buffer H Lysis Buffer, KF PhiX174 DNA / Hinf I Markers 25bp DNA Step Ladder GoTaq MDx Taq Polymerase, Glycerol-Free GoTaq G2 Flexi DNA Polymerase Internal Lane Standard 600 5X PCR Buffer F Lambda DNA / EcoR I Markers GoTaq DNA Polymerase RQ1 RNase-Free Dnase 100bp DNA Ladder BenchTop 1kb DNA Ladder PCR Nucleotide Mix, 25mM rGTP, 100mM Unmethylated Lambda DNA DNA Ladder, 1kb rCTP, rGTP, rUTP, & rATP (100mM each) Abbott mSample Preparation System Bulk mLysisDNA Buffer Kit MagneSil KF, Paramagnetic Particles QuantiFluor ONE ds DNA Dye Abbott mSample Preparation System DBS Buffer Kit Column Wash Solution (CWA) MagneSil PMPs rATP (100mM) DNA Polymerase I Klenow Fragment GoTaq Green Master Mix Recombinant RNasin RNase Inhibitor DNA Polymerase I Large (Klenow) Fragment GoTaq MDx Hot Start Polymerase Acetylated Bovine Serum Albumin dATP, 100mM rATP, 10mM cGMP 1mM GoTaq Colorless Master Mix rProteinase K Solution AOF 10bp DNA Step Ladder BenchTop pGEM DNA Markers dTTP, 100mM pGEM DNA Markers RNase H XpressAmp Direct Amp. Reagents, HT 50bp DNA Step Ladder GoTaq PCR Core System AMV Reverse Transcriptase Maxwell CSC RNA Blood Kit Maxwell® CSC Rapid ccfDNA Kit Maxwell CSC Instrument Maxwell CSC DNA FFPE Kit Maxwell CSC Genomic DNA Kit Maxwell CSC Pathogen Total Nucleic Acid Kit Abbott mSample Preparation System DNA Maxwell CSC RNA FFPE Kit Abbott mSample Preparation System Maxwell CSC Whole Blood DNA Kit Maxwell CSC 48 Instrument Maxwell CSC Viral Total Nucleic Acid Purification Kit Maxwell® CSC XtractAll FFPE DNA/RNA Kit Maxwell CSC Blood DNA Kit OncoMate MSI Dx Analysis System OncoMate 5C Matrix Standard

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PZJ Lynch Syndrome Test System Immunology Class 2 864.1866 2021-08-30
SFL Nucleic Acid Based Assay, Microsatellite Instability Unknown Class 3 N/A 2025-12-17
PEG Nucleic Acid Quantitation Kit Clinical Chemistry Class 1 862.2310 2021-12-08
PPM General Purpose Reagent Pathology Class 1 864.4010 1999-01-08
JJH Clinical Sample Concentrator Clinical Chemistry Class 1 862.2310 2011-04-05
PZJ Lynch Syndrome Test System Immunology Class 2 864.1866 2020-12-01
MAQ Kit, Dna Detection, Human Papillomavirus Unknown Class 3 N/A 2025-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Promega Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009311010 Promega Biosystems Inc. Seoul, KR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2134567. Last updated year: 2026. Please use registration number 2134567 when referencing this establishment in official correspondence.
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