CHROMA ATE

GUDID 04719889100010

MagXtract 3200 Automated Nucleic Acid Extraction System The 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.

CHROMA ATE INC.

Magnetic particle separation instrument IVD, automated

• Primary Device ID: 04719889100010
• NIH Device Record Key: d21164af-597f-4a3d-86b9-099a781c9eda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHROMA ATE
• Version Model Number: MagXtract 3200
• Company DUNS: 656164662
• Company Name: CHROMA ATE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719889100010 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-24
• Device Publish Date: 2022-08-16

On-Brand Devices [CHROMA ATE]

• 04719889100010: MagXtract 3200 Automated Nucleic Acid Extraction System The MagXtract 3200 system is an automate
• 04719889100102: The GenXplore® system is an automated qPCR-based nucleic acid testing system. It can perform nu