Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027518847

FEI Number

3027518847

Entity Name

Phase Scientific (Shenzhen) Company Limited

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 201, 301, No.3 3B, Hengtaiyu Bldg, Tangwei Community, Fenghuang Street, Guangming District, Shenzhen Guangdong 518107, CN

Establishment Type(s)

Repack or Relabel Medical Device

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

K150022

PMA Number

N/A

All Registered Proprietary Names

HR HPV Master Mix HR HPV Enzyme Mix INDICAID Urine Collection Kit Phasify Max Total DNA Extraction Kit INDICAID HCG EARLY RESULT PREGNANCY TEST STRIP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2025-01-15
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2025-01-27
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2024-04-10
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2024-04-10
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2025-05-16
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-05-16

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
3017887566	PHASE SCIENTIFIC INTERNATIONAL LIMITED	Shatin NT, HONG KONG, HK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150022	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	2015-08-07
K964536	Teco Diagnostics	ONE-STEP DIPSTICK PREGNANCY TEST	1997-02-11
K904016	Bhc Biotech , Ltd.	MAXI TEST	1990-10-15
K870259	Leeco Diagnostics, Inc.	VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044	1987-03-10
K820822	Hybritech, Inc.	TANDEM HCG KIT	1982-04-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

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3013059683	ATSI Logistics Center ApS	GLOSTRUP Hovedstaden, DK
3004375571	GLYCOMINDS DIAGNOSTICS (2014) LTD.	Raanana Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027518847. Last updated year: 2026. Please use registration number 3027518847 when referencing this establishment in official correspondence.