Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042159574

FEI Number

3042159574

Entity Name

NOVASCOPE DIAGNOSTICS INC.

City/State/Country

Zhubei Hsinchu (City), TW

Establishment Address

2F-9, No. 38, Taiyuan St.,, Zhubei Hsinchu (City) 302082, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Foreign Private Label Distributor,Manufacture Medical Device

Owner / Operator

Novascope Diagnostics Inc. (Owner Number: 10094402)

Owner / Operator Contact Address

2F-9, No. 38, Taiyuan St.,, Zhubei, TW-HSZ 302082, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Immunohistochemistry Reagents and Kits

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2025-11-26

Official Correspondent

Lily Chen

US Agent Details

Yong Sun Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Novascope Diagnostics 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 3042159574. Last updated year: 2026. Please use registration number 3042159574 when referencing this establishment in official correspondence.