Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017887566

FEI Number

3017887566

Entity Name

PHASE SCIENTIFIC INTERNATIONAL LIMITED

City/State/Country

Shatin NT, HONG KONG, HK

Establishment Address

1/F, Building 22E Phase 3, Hong Kong Science Park, Shatin NT, HONG KONG 00000, HK

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Phase Scientific International Limited (Owner Number: 10083165)

Owner / Operator Contact Address

1/F. Building 22E Phase 3, Hong Kong Science Park, Shatin NT, HK-NOTA 00000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PHASIFY Plasma DNA Extraction Kit-S2 Enrichment PHASIFY MAX cfDNA Extraction Kit PHASIFY ENRICH cfDNA Extraction Kit INDICAID COVID-19 Rapid Antigen Test INDICAID COVID-19 Rapid Antigen At-Home Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OTQ	Research Use Only/Hematology Devices	Unknown	Class N	N/A	2026-02-09
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2021-10-29

Official Correspondent

Ricky Chiu

US Agent Details

Eric Tsang Email: eric.tsang@phasesci.com Phone: (657) 2067035

Related Public Records

Same Entity

Phase Scientific International Limited

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027518847	Phase Scientific (Shenzhen) Company Limited	Shenzhen Guangdong, CN

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017887566. Last updated year: 2026. Please use registration number 3017887566 when referencing this establishment in official correspondence.