Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014223276

FEI Number

3014223276

Entity Name

QINGDAO HIGHTOP BIOTECH CO., LTD.

City/State/Country

Qingdao Shandong, CN

Establishment Address

No.369 Hedong Road, Hi-tech Industrial Development Zone, Qingdao Shandong 266112, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Qingdao HIGHTOP Biotech Co., Ltd. (Owner Number: 10061479)

Owner / Operator Contact Address

No.369 Hedong Road, Hi-tech Industrial Development Zone, Qingdao, CN-SD 266112, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192123

PMA Number

N/A

All Registered Proprietary Names

HIGHTOP (LH) Luteinizing Hormone Rapid Test Cassette HIGHTOP (LH) Luteinizing Hormone Rapid Test Midstream HIGHTOP (LH) Luteinizing Hormone Rapid Test Strip FSH Rapid Test Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel HIGHTOP Pregnancy Rapid Test Strip HIGHTOP Pregnancy Rapid Test Cassette HIGHTOP Pregnancy Rapid Test Midstream

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2019-11-25
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2026-04-03
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-10-22
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2019-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

Joe Xia Business: LSI Email: jxia@lsi-consulting.org Phone: (240) 5057880

Related Public Records

Same Entity

Qingdao HIGHTOP Biotech Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241741	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel	2024-07-16
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10
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
K043443	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE PREGNANCY TEST	2005-04-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

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3013885851	CENTUM ELECTRONICS LIMITED	Bangalore Karnataka, IN
3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014223276. Last updated year: 2026. Please use registration number 3014223276 when referencing this establishment in official correspondence.