Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008054239

FEI Number

3008054239

Entity Name

CORE TECHNOLOGY CO., LTD.

City/State/Country

Changping District Beijing, CN

Establishment Address

29 Life Park Rd., #C100, Changping District Beijing 102206, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Core Technology Co., Ltd. (Owner Number: 10044021)

Owner / Operator Contact Address

29 Life Park Rd., #C100, Changping District, CN-BJ 102206, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CorDx COVID-19 Ag Test Genabio COVID-19 Rapid Self-Test Kit Coretests Ovulation Test Midstream Coretests Ovulation Test Strip ACCU NEWS Ovulation Test + Pregnancy Test Combo CorDx Tyfast Ovulation Test Strip CorDx Tyfast Ovulation Test + Pregnancy Test Combo Coretests Ovulation Test Cassette CorDx Tyfast Ovulation Test Cassette CorDx Tyfast Ovulation Test Midstream CorDx Tyfast Pregnancy Test Cassette ACCU NEWS Pregnancy Test Strip ACCU NEWS One Step hCG Pregnancy Test Strip ACCU NEWS Pregnancy Test Midstream ACCU NEWS One Step hCG Pregnancy Test Midstream ACCU NEWS Ovulation Test + Pregnancy Test Combo ACCU NEWS One Step hCG Pregnancy Test Cassette ACCU NEWS Pregnancy Test Cassette CorDx Tyfast Pregnancy Test Midstream CorDx Tyfast Pregnancy Test Strip CorDx Tyfast Multi-Drug Rapid Test Cup CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test ACCU NEWS Single Drug Screen Test, COC Test ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP) ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP) ACCU NEWS Single Drug Screen Test, THC Test TyFast Drug Screening Urine Card CorDx Drug Screening Urine Cup CorDx Drug Screening Test Card TyFast Drug Screening Urine Cup CorDx Tyfast FSH Rapid Test Cassette CorDx Tyfast FSH Rapid Test Strip CorDx Tyfast FSH Rapid Test Midstream

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2022-07-29
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2013-04-18
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2016-01-18
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-04-28
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-04-28
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2026-04-28
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2024-03-28
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2016-08-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2016-08-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2016-08-12
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2016-08-12
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2016-08-12
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2026-02-24

Official Correspondent

Chen Lizhu

US Agent Details

Vicky Huang Business: CorDx, Inc. Email: 6509@coretests.com Phone: (858) 8886916

Related Public Records

Same Entity

Core Technology 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
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
K173229	Guangzhou Wondfo Biotech Co., Ltd.	Preview Digital Pregnancy Test	2018-03-12

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
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
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008054239. Last updated year: 2026. Please use registration number 3008054239 when referencing this establishment in official correspondence.