Core Technology Co., Ltd.
Manufacturer and brand owner in Changping District, Beijing, China. 14 device types, 1 product catalogued, 4 clearances.
Core Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Amphetamine and 12 other device types. Its earliest product listing with the FDA dates from 2013.
14device types registered with the FDA
1product
4510(k) clearances
Registration
| Registered name | CORE TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008054239 |
| FEI number | 3008054239 |
| DUNS | 724425892 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 北京库尔科技有限公司 |
|---|---|
| Unified social credit code | 91110114785541383H |
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Changping District |
|---|---|
| Province | Beijing |
| Address | 29 Life Park Rd., #C100 |
| Postal code | 102206 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | Class N | Genabio COVID-19 Rapid Self-Test Kit, CorDx COVID-19 Ag Test | 2022 | 12 |
| Covid-19 Multi-Analyte Antigen Device | Class N | CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test, CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test | 2024 | 7 |
| Enzyme Immunoassay, Amphetamine | Class 2 | ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP), ACCU NEWS Single Drug Screen Test, THC Test, ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP), ACCU NEWS Single Drug Screen Test, COC Test, TyFast Drug Screening Urine Card, TyFast Drug Screening Urine Cup and 2 more | 2016 | 16 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP), ACCU NEWS Single Drug Screen Test, THC Test, ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP), ACCU NEWS Single Drug Screen Test, COC Test, TyFast Drug Screening Urine Card, TyFast Drug Screening Urine Cup and 2 more | 2016 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP), ACCU NEWS Single Drug Screen Test, THC Test, ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP), ACCU NEWS Single Drug Screen Test, COC Test, TyFast Drug Screening Urine Card, TyFast Drug Screening Urine Cup and 2 more | 2016 | 16 |
| Enzyme Immunoassay, Opiates | Class 2 | ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP), ACCU NEWS Single Drug Screen Test, THC Test, ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP), ACCU NEWS Single Drug Screen Test, COC Test, TyFast Drug Screening Urine Card, TyFast Drug Screening Urine Cup and 2 more | 2016 | 17 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | CorDx Tyfast Pregnancy Test Cassette, ACCU NEWS One Step hCG Pregnancy Test Cassette, ACCU NEWS Pregnancy Test Cassette, ACCU NEWS One Step hCG Pregnancy Test Midstream, CorDx Tyfast Pregnancy Test Strip, CorDx Tyfast Pregnancy Test Midstream and 4 more | 2016 | 30 |
| Test System, Nicotine, Cotinine, Metabolites | Class 1 | CorDx Tyfast Cotinine (COT) Rapid Test Cassette, CorDx Tyfast Cotinine (COT) Rapid Test Strip | 2026 | 11 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | CorDx Tyfast FSH Rapid Test Cassette, CorDx Tyfast FSH Rapid Test Strip, CorDx Tyfast FSH Rapid Test Midstream | 2026 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Coretests Ovulation Test Cassette, ACCU NEWS Ovulation Test + Pregnancy Test Combo, CorDx Tyfast Ovulation Test Midstream, CorDx Tyfast Ovulation Test Strip, CorDx Tyfast Ovulation Test + Pregnancy Test Combo, CorDx Tyfast Ovulation Test Cassette and 2 more | 2013 | 38 |
| Test, Methadone, Over The Counter | Class 2 | CorDx Tyfast Multi-Drug Rapid Test Cup | 2026 | 17 |
| Test, Opiates, Over The Counter | Class 2 | CorDx Tyfast Multi-Drug Rapid Test Cup | 2026 | 18 |
| Test, Propoxyphene, Over The Counter | Class 2 | CorDx Tyfast Multi-Drug Rapid Test Cup | 2026 | 16 |
| Thin Layer Chromatography, Methamphetamine | Class 2 | ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP), ACCU NEWS Single Drug Screen Test, THC Test, ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP), ACCU NEWS Single Drug Screen Test, COC Test, TyFast Drug Screening Urine Card, TyFast Drug Screening Urine Cup and 2 more | 2016 | 12 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K964230 | 1997-07-24 | FMF | Traditional | This company |
| K924271 | 1992-11-23 | FCG | Traditional | This company |
| K924270 | 1992-09-23 | GDF | Traditional | This company |
| K914732 | 1992-01-07 | FCG | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Factory area | 1,200 sq meters GMP workshop |
| Main products | Rapid diagnostic tests, Fertility tests, Infectious disease tests, Cardiac marker tests, COVID-19 tests |
| Certifications | ISO 9001, ISO 13485, EU CE |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Beijing AK Medical Co., Ltd. | 3 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.