CHROMA ATE - MagXtract 3200 Automated Nucleic Acid Extraction - CHROMA ATE INC.

Duns Number:656164662

Device Description: MagXtract 3200 Automated Nucleic Acid Extraction SystemThe MagXtract 3200 system is an aut MagXtract 3200 Automated Nucleic Acid Extraction SystemThe MagXtract 3200 system is an automated nucleic acid purification and PCR reaction preparation system consisting of MagXtract 3200 instrument, software and consumables. It must be used in combination with the authorized extraction kits which have been validated according to the IVD or other relevant regulations to perform the nucleic acid purifications. The MagXtract 3200 System is intended for use by professional users for the purification of nucleic acids and PCR sample prep from human samples for in vitro diagnostic purposes.Product Use Limitations:The MagXtract 3200 instrument is intended for indoor use only. The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using nucleic acids, purified by the instruments.

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More Product Details

Catalog Number

-

Brand Name

CHROMA ATE

Version/Model Number

MagXtract 3200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

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For Single-Use

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Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JJH

Product Code Name

Clinical Sample Concentrator

Device Record Status

Public Device Record Key

d21164af-597f-4a3d-86b9-099a781c9eda

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

August 16, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHROMA ATE INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1