Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003083993

FEI Number

3003083993

Entity Name

CHROMA ATE INC.

City/State/Country

Guishan District Taoyuan, TW

Establishment Address

88 Wenmao Road, Guishan District Taoyuan 333001, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Chroma ATE Inc. (Owner Number: 10081652)

Owner / Operator Contact Address

No. 88, Wenmao Rd., Guishan Dist., Taoyuan, TW-NOTA 333001, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MagXtract 3200 Automated Nucleic Acid Extraction System GenXplore q4800 Automated qPCR-based Nucleic Acid Testing System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2021-05-03
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2024-06-04

Official Correspondent

Victor Chen

US Agent Details

Ho Shan Wang Email: acmebiotechs@gmail.com Phone: (623) 9864377

Related Public Records

Same Entity

Chroma ATE Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003083993. Last updated year: 2026. Please use registration number 3003083993 when referencing this establishment in official correspondence.