Promega Corp

FDA Filings

This page includes the latest FDA filings for Promega Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Promega Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Carol E Lindsay

FDA Registration(s)

• Registration Number: 3009311010
• FEI Number: 3009311010
• Name: Carol E Lindsay
• Owner & Operator: Promega Corporation
• Contact Address: 2800 Woods Hollow Road --; Madison WI 53711 US
• US Agent:
  • Carol E Lindsay
  • PROMEGA CORPORATION
  • 608 2744330 1330
  • 608 2772516
  • carol.lindsay@promega.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2800 Woods Hollow Road ; Madison, WI 53711 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 2134567
• FEI Number: 3002622561
• Name: Promega Corporation
• Owner & Operator: Promega Corporation
• Contact Address: 2800 Woods Hollow Road --; Madison WI 53711 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2800 Woods Hollow Road ; Madison, WI 53711 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 00849811075902 PROMEGA CORPORATION	QuantiFluor® Dx dsDNA System E5900	2023-08-23
GUDID 00849811069062 PROMEGA CORPORATION	Maxwell® CSC Pathogen Total Nucleic Acid Kit AS1860	2023-06-20
GUDID 00849811066115 PROMEGA CORPORATION	Maxwell® CSC Genomic DNA Kit AS1850	2023-06-20
GUDID 00849811064647 PROMEGA CORPORATION	Maxwell® CSC Whole Blood DNA Kit AS1820	2022-02-09
GUDID 00849811060991 PROMEGA CORPORATION	Maxwell® CSC 48 Instrument AS8000	2022-02-09
GUDID 00849811060960 PROMEGA CORPORATION	Maxwell® CSC Viral Total Nucleic Acid Purification Kit AS1780	2022-02-09
GUDID 00849811051777 PROMEGA CORPORATION	Maxwell® CSC Blood DNA Kit AS1321	2022-02-09
GUDID 00849811051753 PROMEGA CORPORATION	Maxwell® CSC DNA FFPE Kit AS1350	2022-02-09
GUDID 00849811051746 PROMEGA CORPORATION	Maxwell® CSC RNA FFPE Kit AS1360	2022-02-09
GUDID 00849811051739 PROMEGA CORPORATION	Maxwell® CSC RNA Blood Kit AS1410	2022-02-09
GUDID 00849811051340 PROMEGA CORPORATION	Maxwell® CSC Instrument AS6000	2022-02-09
GUDID 00849811056864 PROMEGA CORPORATION	OncoMate MSI Dx Assay Installer MD4150	2021-10-18
GUDID 00849811056857 PROMEGA CORPORATION	OncoMate MSI Dx Interpretive Software MD4140	2021-10-18
GUDID 00849811050619 PROMEGA CORPORATION	OncoMate 5C Matrix Standard MD4850	2021-10-08
GUDID 00849811031717 PROMEGA CORPORATION	OncoMate MSI Dx Analysis System MD2140	2021-10-08
PMN K200129 Promega Corporation	OncoMate MSI Dx Analysis System	2021-07-26
GUDID 00849811004636 PROMEGA CORPORATION	Abbott mSample Preparation System RNA Bulk Lysis Buffer Kit 02N77-01	2018-03-29
GUDID 00849811004483 PROMEGA CORPORATION	Abbott mSample Preparation System DBS Buffer Kit 08N80-001	2018-03-29
GUDID 00849811004452 PROMEGA CORPORATION	Abbott mSample Preparation System DNA 06K12-24	2018-03-29
GUDID 00849811004445 PROMEGA CORPORATION	Abbott mSample Preparation System 04J70-24	2018-03-29
JJH Promega Corporation	Maxwell CSC RNA FFPE Kit	2011-04-05
JJH Promega Corporation	Maxwell CSC RNA Blood Kit	2011-04-05
JJH Promega Corporation	Maxwell CSC Instrument	2011-04-05
JJH Promega Corporation	Maxwell CSC DNA FFPE Kit	2011-04-05
JJH Promega Corporation	Maxwell CSC Blood DNA Kit	2011-04-05
JJH Promega Corporation	Abbott mSample Preparation System	2011-04-05
JJH Promega Corporation	Abbott mSample Preparation System DNA	2011-04-05
JJH Carol E Lindsay [Promega Corporation]	Maxwell CSC RNA FFPE Kit	2011-04-05
JJH Carol E Lindsay [Promega Corporation]	Maxwell CSC RNA Blood Kit	2011-04-05
JJH Carol E Lindsay [Promega Corporation]	Maxwell CSC Instrument	2011-04-05
JJH Carol E Lindsay [Promega Corporation]	Maxwell CSC DNA FFPE Kit	2011-04-05
JJH Carol E Lindsay [Promega Corporation]	Maxwell CSC Blood DNA Kit	2011-04-05
JJH Carol E Lindsay [Promega Corporation]	Abbott mSample Preparation System	2011-04-05
JJH Carol E Lindsay [Promega Corporation]	Abbott mSample Preparation System DNA	2011-04-05
MNA Promega Corporation	Y Chromosome AZF Analysis System	2007-11-29
PPM Promega Corporation	rUTP, 10mM	1999-01-08
PPM Promega Corporation	rUTP, 100mM	1999-01-08
PPM Promega Corporation	rGTP, 10mM	1999-01-08
PPM Promega Corporation	rGTP, 100mM	1999-01-08
PPM Promega Corporation	rCTP, rGTP, rUTP, & rATP (100mM ea)	1999-01-08
PPM Promega Corporation	rCTP, 10mM	1999-01-08
PPM Promega Corporation	rCTP (100mM)	1999-01-08
PPM Promega Corporation	rATP, rCTP, rGTP, rUTP each at 10mM	1999-01-08
PPM Promega Corporation	rATP, 10mM	1999-01-08
PPM Promega Corporation	rATP (100mM)	1999-01-08
PPM Promega Corporation	pGEM DNA Markers	1999-01-08
PPM Promega Corporation	eLysis Buffer	1999-01-08
PPM Promega Corporation	dUTP, 100mM	1999-01-08
PPM Promega Corporation	dTTP, 100mM	1999-01-08
PPM Promega Corporation	dNTP Mix, 10mM	1999-01-08
PPM Promega Corporation	dGTP, 100mM	1999-01-08
PPM Promega Corporation	dCTP, 100mM	1999-01-08
PPM Promega Corporation	dATP, 100mM	1999-01-08
PPM Promega Corporation	cGMP 1mM	1999-01-08
PPM Promega Corporation	cAMP	1999-01-08
PPM Promega Corporation	Unmethylated Lambda DNA	1999-01-08
PPM Promega Corporation	T4 DNA Ligase	1999-01-08
PPM Promega Corporation	T4 DNA Ligase (HC)	1999-01-08
PPM Promega Corporation	Streptavidin MagneSphere Paramagnetic Particles	1999-01-08
PPM Promega Corporation	Set of dUTP, dCTP, dGTP, dATP 100mM each	1999-01-08
PPM Promega Corporation	Seq Grade Modified Trypsin, Bulk Sale Size	1999-01-08
PPM Promega Corporation	Reverse Transcription 10X Buffer	1999-01-08
PPM Promega Corporation	Recombinant RNasin RNase Inhibitor	1999-01-08
PPM Promega Corporation	RQ1 RNase-Free Dnase	1999-01-08
PPM Promega Corporation	RNasin Plus RNase Inhibitor	1999-01-08
PPM Promega Corporation	RNase ONE Ribonuclease	1999-01-08
PPM Promega Corporation	RNase H	1999-01-08
PPM Promega Corporation	QuantiFluor dsDNA System	1999-01-08
PPM Promega Corporation	QuantiFluor ONE ds DNA Dye	1999-01-08
PPM Promega Corporation	PhiX174 DNA / Hinf I Markers	1999-01-08
PPM Promega Corporation	PhiX174 DNA / Hae III Markers	1999-01-08
PPM Promega Corporation	PCR Optimization Kit	1999-01-08
PPM Promega Corporation	PCR Nucleotide Mix, 25mM	1999-01-08
PPM Promega Corporation	PCR Nucleotide Mix, 10mM	1999-01-08
PPM Promega Corporation	PCR Master Mix (2X)	1999-01-08
PPM Promega Corporation	PCR Marker	1999-01-08
PPM Promega Corporation	Nuclease-Free Water	1999-01-08
PPM Promega Corporation	Maxwell 16 Viral Total Nucleic Acid Purification Kit	1999-01-08
PPM Promega Corporation	Maxwell 16 Tissue LEV Total RNA Purifation Kit	1999-01-08
PPM Promega Corporation	Maxwell 16 Tissue DNA Purification Kit	1999-01-08
PPM Promega Corporation	Maxwell 16 LEV simplyRNA Tissue Kit	1999-01-08
PPM Promega Corporation	Maxwell 16 LEV simplyRNA Cells Kit	1999-01-08
PPM Promega Corporation	Maxwell 16 LEV Blood DNA Kit	1999-01-08
PPM Promega Corporation	Maxwell 16 FFPE Tissue LEV DNA Purification Kit	1999-01-08
PPM Promega Corporation	Maxwell 16 FFPE Plus LEV DNA Purification Kit	1999-01-08
PPM Promega Corporation	Maxwell 16 Cell LEV Total RNA Purifation Kit	1999-01-08
PPM Promega Corporation	Maxwell 16 Cell LEV DNA Purification	1999-01-08
PPM Promega Corporation	Maxwell 16 Cell DNA Purification Kit	1999-01-08
PPM Promega Corporation	Maxwell 16 Buccal Swab LEV DNA Purification Kit	1999-01-08
PPM Promega Corporation	Maxwell 16 Blood DNA Purification Kit	1999-01-08
PPM Promega Corporation	Magnesium Chloride Solution, 25mM	1999-01-08
PPM Promega Corporation	MagneSil PMPs	1999-01-08
PPM Promega Corporation	MagneSil KF, Paramagnetic Particles	1999-01-08
PPM Promega Corporation	M-MLV Reverse Transcriptase	1999-01-08
PPM Promega Corporation	M-MLV Reverse Transcriptase Buffer Pack	1999-01-08
PPM Promega Corporation	Lysis Buffer, KF	1999-01-08
PPM Promega Corporation	Lambda DNA	1999-01-08
PPM Promega Corporation	Lambda DNA / Hind III Markers	1999-01-08
PPM Promega Corporation	Lambda DNA / EcoR I Markers	1999-01-08
PPM Promega Corporation	Lambda DNA / EcoR I + Hind III Markers	1999-01-08
PPM Promega Corporation	Klenow Fragment, Exonuclease Minus	1999-01-08
PPM Promega Corporation	Internal Lane Standard 600	1999-01-08
PPM Promega Corporation	ImProm-II? Reverse Transcriptase	1999-01-08
PPM Promega Corporation	Human Genomic DNA	1999-01-08
PPM Promega Corporation	Human Genomic DNA: Male	1999-01-08
PPM Promega Corporation	Human Genomic DNA: Female	1999-01-08
PPM Promega Corporation	Herring Sperm DNA	1999-01-08
PPM Promega Corporation	GoTaq Probe 1-Step RT-qPCR System	1999-01-08
PPM Promega Corporation	GoTaq PCR Core System	1999-01-08
PPM Promega Corporation	GoTaq MDx Taq Polymerase	1999-01-08
PPM Promega Corporation	GoTaq MDx Taq Polymerase, Glycerol-Free	1999-01-08
PPM Promega Corporation	GoTaq MDx Hot Start Polymerase	1999-01-08
PPM Promega Corporation	GoTaq MDx Hot Start Polymerase, Glycerol-Free	1999-01-08
PPM Promega Corporation	GoTaq Green Master Mix	1999-01-08
PPM Promega Corporation	GoTaq G2 Green Master Mix	1999-01-08
PPM Promega Corporation	GoTaq G2 Flexi DNA Polymerase	1999-01-08
PPM Promega Corporation	GoTaq G2 DNA Polymerase	1999-01-08
PPM Promega Corporation	GoTaq G2 Colorless Master Mix	1999-01-08
PPM Promega Corporation	GoTaq Flexi DNA Polymerase	1999-01-08
PPM Promega Corporation	GoTaq DNA Polymerase	1999-01-08
PPM Promega Corporation	GoTaq Colorless Master Mix	1999-01-08
PPM Promega Corporation	GoScript Reverse Transcriptase	1999-01-08
PPM Promega Corporation	Deoxynucleotide Triphosphates, 100mM	1999-01-08
PPM Promega Corporation	DTT, 100mM	1999-01-08
PPM Promega Corporation	DNA Polymerase I Large (Klenow) Fragment	1999-01-08
PPM Promega Corporation	DNA Polymerase I Klenow Fragment	1999-01-08
PPM Promega Corporation	DNA Ladder, 1kb	1999-01-08
PPM Promega Corporation	Column Wash Solution (CWA)	1999-01-08
PPM Promega Corporation	BenchTop pGEM DNA Markers	1999-01-08
PPM Promega Corporation	BenchTop PhiX174 DNA/Hae III Markers	1999-01-08
PPM Promega Corporation	BenchTop PCR Markers	1999-01-08
PPM Promega Corporation	BenchTop 1kb DNA Ladder	1999-01-08
PPM Promega Corporation	BenchTop 100bp DNA Ladder	1999-01-08
PPM Promega Corporation	BCIP/NBT Color Development Substrate	1999-01-08
PPM Promega Corporation	Anti-Foam Reagent	1999-01-08
PPM Promega Corporation	Alcohol Wash, Blood	1999-01-08
PPM Promega Corporation	Acetylated Bovine Serum Albumin	1999-01-08
PPM Promega Corporation	Abbott mSample Preparation System DBS Buffer Kit 08N80-001	1999-01-08
PPM Promega Corporation	Abbott mSample Preparation System Bulk mLysisDNA Buffer Kit	1999-01-08
PPM Promega Corporation	AMV Reverse Transcriptase	1999-01-08
PPM Promega Corporation	AMV Reverse Transcriptase (HC)	1999-01-08
PPM Promega Corporation	5X PCR Buffer H	1999-01-08
PPM Promega Corporation	5X PCR Buffer G	1999-01-08
PPM Promega Corporation	5X PCR Buffer F	1999-01-08
PPM Promega Corporation	5X PCR Buffer E	1999-01-08
PPM Promega Corporation	5X PCR Buffer D	1999-01-08
PPM Promega Corporation	5X PCR Buffer C	1999-01-08
PPM Promega Corporation	5X PCR Buffer B	1999-01-08
PPM Promega Corporation	5X PCR Buffer A	1999-01-08
PPM Promega Corporation	5X Green GoTaq Reaction Buffer	1999-01-08
PPM Promega Corporation	5X Green GoTaq Flexi Reaction Buffer	1999-01-08
PPM Promega Corporation	5X Colorless GoTaq Reaction Buffer	1999-01-08
PPM Promega Corporation	5X Colorless GoTaq Flexi Reaction Buffer	1999-01-08
PPM Promega Corporation	50bp DNA Step Ladder	1999-01-08
PPM Promega Corporation	25bp DNA Step Ladder	1999-01-08
PPM Promega Corporation	200bp DNA Step Ladder	1999-01-08
PPM Promega Corporation	1kb DNA Step Ladder	1999-01-08
PPM Promega Corporation	10bp DNA Step Ladder	1999-01-08
PPM Promega Corporation	100bp DNA Step Ladder	1999-01-08
PPM Promega Corporation	100bp DNA Ladder	1999-01-08

Related Finance Registrations

NCAGE Code	0K9T4	PROMEGA CORPORATION
NCAGE Code	Z3N24	PROMEGA CORPORATION
CAGE Code	0K9T4	PROMEGA CORPORATION
CAGE Code	Z3N24	PROMEGA CORPORATION
S.A.M. Registration	0K9T4 [89855696]	PROMEGA CORPORATION

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091256528	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	PLASTIC CONTAINERS	6 PKG
2020041554631	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	PLSATIC PACKAGING	4 PKG
2018020628785	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	CATALOGUE	172 CTN