Data / Medical devices / United States / Promega Corporation
Promega Corporation: FDA-registered device maker in Madison, WI, United States, 1 510(k) clearance and 1 PMA approval
Promega Corporation is registered with the FDA (registration 2134567) in Madison, WI, United States. It lists 6 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated November 5, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2134567
- FEI number
- 3002622561
- Address
- 2800 Woods Hollow Road, Madison, WI, United States, 53711
- Owner or operator
- Promega Corporation (9036108)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- January 8, 1999
- Registered through
- 2026
- Brand names listed
- 100bp DNA Ladder, 100bp DNA Step Ladder, 10bp DNA Step Ladder, 1kb DNA Step Ladder, 200bp DNA Step Ladder, 25bp DNA Step Ladder, 50bp DNA Step Ladder, 5X Colorless GoTaq Flexi Reaction Buffer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | 1 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Kit, Dna Detection, Human Papillomavirus | MAQ | 3 | Manufacturer for export | accessdata.fda.gov |
| Lynch Syndrome Test System | PZJ | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Nucleic Acid Based Assay, Microsatellite Instability | SFL | 3 | Manufacturer | accessdata.fda.gov |
| Nucleic Acid Quantitation Kit | PEG | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 26, 2021 | K200129 | OncoMate MSI Dx Analysis System | PZJ | Substantially Equivalent | Promega Corporation | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 5, 2025 | P240026 | OncoMate® MSI Dx Analysis System | SFL | 0 | November 5, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 4, 2008 | 49586 | Not yet classified | Terminated | RNAgents Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label. For Laboratory Use. Promega Corporation, Madison, WI. USA. Bottle Label: Phenol: Chloroform: Isoamyl Alcohol (Cat.# Z5112). Part Two of | Promega Corporation received reports of leaking bottles of Phenol:Chloroform:Isoamyl Alcohol (Part # Z5112), a component of the RNAgents Total RNA Isolation System (Catalog # Z5110). Promega product Z5112 is a mixture of phenol, chloroform and isoamyl alcohol. If phenol contacts skin, it can cause burns and poisoning. The fumes of this product are also harmf | accessdata.fda.gov |
Compare with other makers
- All makers of Kit, Dna Detection, Human Papillomavirus
- All makers of General Purpose Reagent
- All makers of Lynch Syndrome Test System
- All makers of Clinical Sample Concentrator
Updated November 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.