CHROMA ATE INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3003083993	3003083993	CHROMA ATE INC.	1	N	2026-01-01	88 Wenmao Road Guishan District Taoyuan TW 333001

Registered Device Listings#

Registration key, Listing key table
Registration key	Listing key
292056	1529340877
292056	1668237631

GUDID#

CHROMA ATE - The GenXplore® system is an automated qPCR-based nucleic acid testing system. It can perform nucleic acid extraction, liquid handling, thermal cycling, and real-time fluorescence detection for testing nucleic acids from human samples, specifically for in vitro diagnostic purposes. The GenXplore® system is intended for professional use only and indoor use only.

CHROMA ATE INC.

2024-07-26

CHROMA ATE - 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.

CHROMA ATE INC.

2022-08-16