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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lynch Syndrome Test System | PZJ | Class 2 | Immunology | No | 2021-08-30 |
| Nucleic Acid Based Assay, Microsatellite Instability | SFL | Class 3 | Unknown | No | 2025-12-17 |
| Nucleic Acid Quantitation Kit | PEG | Class 1 | Clinical Chemistry | No | 2021-12-08 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 1999-01-08 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2011-04-05 |
| Kit, Dna Detection, Human Papillomavirus | MAQ | Class 3 | Unknown | No | 2025-12-17 |
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