PROMEGA CORPORATION

Address:2800 Woods Hollow Road,Madison,WI,53711,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Clinical Sample Concentrator (JJH) (4) Lynch Syndrome Test System (PZJ) (2)

Premarket Exempt

No Yes

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Maxwell® CSC Blood DNA Kit - 00849811051777 Catalog Number : AS1321

Device Description : The Maxwell® CSC Blood DNA kit is a reagent kit used in combination with Maxwell The Maxwell® CSC Blood DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of genomic DNA from whole human blood samples.

Device Class : 1

Duns Number: 089855696

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

OncoMate MSI Dx Interpretive Software - 00849811056857 Catalog Number : MD4140

Device Description : Software used to interpret data obtained using the OncoMate MSI Dx Analysis System.

Device Class : 2

Duns Number: 089855696

Premarket Exempt : No

Product Code : PZJ

Prescription Use : No

Device Count : 1

OncoMate MSI Dx Assay Installer - 00849811056864 Catalog Number : MD4150

Device Description : Software for installing OncoMate MSI Dx Analysis System assay method on the 3500 Software for installing OncoMate MSI Dx Analysis System assay method on the 3500Dx Genetic Analyzer

Device Class : 2

Duns Number: 089855696

Premarket Exempt : No

Product Code : PZJ

Prescription Use : No

Device Count : 1

Maxwell® CSC Viral Total Nucleic Acid Purification Kit - 00849811060960 Catalog Number : AS1780

Device Description : The Maxwell® CSC Viral Total Nucleic Acid Purification DNA kit is a reagent kit The Maxwell® CSC Viral Total Nucleic Acid Purification DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of viral total nucleic acid from human samples.

Device Class : 1

Duns Number: 089855696

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Maxwell® CSC 48 Instrument - 00849811060991 Catalog Number : AS8000

Device Description : The Maxwell® CSC 48 Instrument is a nucleic acid extraction instrument used in c The Maxwell® CSC 48 Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.

Device Class : 1

Duns Number: 089855696

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Maxwell® CSC Whole Blood DNA Kit - 00849811064647 Catalog Number : AS1820

Device Class : 1

Duns Number: 089855696

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

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