FDA Registration Active 🇺🇸 United States

Promega Corporation

Reg #: 2134567 · FEI: 3002622561 · Expires 2026
Products
6
Proprietary Names
135
Establishment Types
5
Classifications
6

Registration Details

Registration Name
Promega Corporation
Registration Number
2134567
FEI Number
3002622561
Status
Active
Expiry Year
2026
Initial Importer
No
Address
2800 Woods Hollow Road
City
Madison
State
WI
ZIP
53711
Country
US

Regulatory Submissions

510(k) Number
K200129
PMA Number
P240026

Owner / Operator

Firm Name
Promega Corporation
Operator Number
9036108
Address
2800 Woods Hollow Road, --
City
Madison
State
WI
Postal Code
53711
Country
US

Products

Device Name Product Code
Lynch Syndrome Test System PZJ
Nucleic Acid Based Assay, Microsatellite Instability SFL
Nucleic Acid Quantitation Kit PEG
General Purpose Reagent PPM
Clinical Sample Concentrator JJH
Kit, Dna Detection, Human Papillomavirus MAQ

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

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only