CHROMA ATE INC.

Address:68 Huaya 1st Road, Guishan,Taoyuan,TW

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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) (1)

Premarket Exempt

Yes

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CHROMA ATE - 04719889100010 Catalog Number :

Device Description : MagXtract 3200 Automated Nucleic Acid Extraction SystemThe MagXtract 3200 system 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.

Device Class : 1

Duns Number: 656164662

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

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