Data / Medical devices / Hong Kong / Phase Scientific International Limited

Phase Scientific International Limited: FDA-registered device maker in Shatin NT, HONG KONG, Hong Kong, 1 510(k) clearance

Name: Phase Scientific International Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Phase Scientific International Limited is registered with the FDA (registration 3017887566) in Shatin NT, HONG KONG, Hong Kong. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 7, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017887566
Address: 1/F, Building 22E Phase 3 Hong Kong Science Park, Shatin NT, HONG KONG, Hong Kong, 00000
Owner or operator: Phase Scientific International Limited (10083165)
Roles: Complaint file establishment, Exporter to the US, Manufacturer
First device listed: October 29, 2021
Registered through: 2026
Brand names listed: INDICAID COVID-19 Rapid Antigen At-Home Test, INDICAID COVID-19 Rapid Antigen Test, INDICAID HCG EARLY RESULT PREGNANCY TEST STRIP, PHASIFY ENRICH cfDNA Extraction Kit, PHASIFY MAX cfDNA Extraction Kit, PHASIFY Plasma DNA Extraction Kit-S2 Enrichment, PHASIFY Urine DNA Extraction Kit-S2 Enrichment, Phasify Total DNA Extraction Kit 2

Devices it lists

Device	Product code	Class	Role	Source
Coronavirus Antigen Detection Test System.	QKP	N	Complaint file establishment, Manufacturer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Exporter to the US	accessdata.fda.gov
Research Use Only/Clinical Chemistry Devices	OTV	N	Manufacturer	accessdata.fda.gov
Research Use Only/Hematology Devices	OTQ	N	Manufacturer	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 7, 2015	K150022	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	LCX	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 25, 2023	93626	Class II	Ongoing	INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040	COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.	accessdata.fda.gov

Compare with other makers

Updated January 17, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.