Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 35 device types, 71 products catalogued, 8 clearances.
Guangzhou Decheng Biotechnology Co., Ltd. is a complaint-file establishment holding a current FDA establishment registration. The registration covers Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Methadone and 33 other device types. 69 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
35device types registered with the FDA
71products catalogued under its own name
8510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3017904598 |
| FEI number | 3017904598 |
| DUNS | 554534314 |
| Establishment type | Complaint-file establishment, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 广州德成生物科技有限公司 |
|---|---|
| Unified social credit code | 91440101MA5CKKAA6M |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District |
| Postal code | 510663 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Enzyme Immunoassay, Amphetamine | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 16 |
| Enzyme Immunoassay, Barbiturate | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 12 |
| Enzyme Immunoassay, Benzodiazepine | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 13 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 16 |
| Enzyme Immunoassay, Methadone | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 11 |
| Enzyme Immunoassay, Opiates | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 17 |
| Enzyme Immunoassay, Phencyclidine | Class U | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 16 |
| Enzyme Immunoassay, Propoxyphene | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 10 |
| Immunoassay, Pregnanediol Glucuronide, Over The Counter | Class 1 | Carethetic® PdG Urine Test, easy@Home® PdG Urine Test, One Step® Progesterone (PdG) Urine Test Strip, PdG Urine Test Strip | 2023 | 4 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | Amazewell™ Digital Pregnancy Rapid Test, BABYlife™ DIGITAL PREGNANCY TEST, BEB® Digital Pregnancy Rapid Test, pregmate Digital Pregnancy Test, Digital Pregnancy Rapid Test, Hy-Vee® Digital Pregnancy Rapid Test and 39 more | 2023 | 30 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 9 |
| Test System, Nicotine, Cotinine, Metabolites | Class 1 | Amazewell™ D-Pen™ Mini COT Oral Fluid Test, UScreen Oral® Saliva Drug Test Pen | 2023 | 11 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | Class 2 | Amazewell™ D-Pen™ Oral Fluid Drug Test, Amazewell™ Lollipop Oral Fluid Drug Test, MGC Health™ D-PEN™ Oral Fluid Drug Test, CVSHealth® 6 Drugs Oral Test Kit, UScreen Oral® Saliva Drug Test Pen | 2023 | 11 |
| Test, Amphetamine, Over The Counter | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 16 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | Class 2 | Amazewell™ Lollipop Oral Fluid Drug Test, UScreen Oral® Saliva Drug Test Pen, Amazewell™ D-Pen™ Oral Fluid Drug Test, MGC Health™ D-PEN™ Oral Fluid Drug Test | 2023 | 11 |
| Test, Barbiturate, Over The Counter | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 16 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | Class 2 | UScreen Oral® Saliva Drug Test Pen | 2024 | 11 |
| Test, Benzodiazepine, Over The Counter | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 16 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | Class 2 | CVSHealth® 1 Drug Oral Test Kit, Amazewell™ Lollipop Oral Fluid Drug Test, Amazewell™ D-Pen™ Mini THC Oral Fluid Test, UScreen Oral® Saliva Drug Test Pen, MGC Health™ D-PEN™ Mini THC Oral Fluid Test, CVSHealth® 6 Drugs Oral Test Kit and 2 more | 2023 | 12 |
| Test, Cannabinoid, Over The Counter | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 16 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | Class 2 | Amazewell™ D-Pen™ Oral Fluid Drug Test, CVSHealth® 6 Drugs Oral Test Kit, MGC Health™ D-PEN™ Mini COC Oral Fluid Test, Amazewell™ Lollipop Oral Fluid Drug Test, UScreen Oral® Saliva Drug Test Pen, MGC Health™ D-PEN™ Oral Fluid Drug Test | 2023 | 12 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 16 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | FSH Urine Test, VeriQuick® At Home Menopause Test Strip, easy@Home® FSH Urine Test, Pregmate® Menopause Test Strips, SURESIGN™ Menopause (FSH) Rapid Test | 2025 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | pregmate® Ovulation Test, easy@Home® Ovulation Test, SURESIGN™ Digital Ovulation Rapid Test Stick, SURESIGN™ Ovulation Rapid Test Midstream, Hy-Vee® Ovulation Kit, SURESIGN™ Digital Ovulation Rapid Test and 21 more | 2021 | 38 |
| Test, Methadone, Employment And Insurance Testing, Exempt | Class 2 | Amazewell™ D-Pen™ Oral Fluid Drug Test, Amazewell™ Lollipop Oral Fluid Drug Test, UScreen Oral® Saliva Drug Test Pen, MGC Health™ D-PEN™ Oral Fluid Drug Test | 2023 | 11 |
| Test, Methadone, Over The Counter | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 17 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | Class 2 | Amazewell™ D-Pen™ Oral Fluid Drug Test, Amazewell™ Lollipop Oral Fluid Drug Test, MGC Health™ D-PEN™ Oral Fluid Drug Test, UScreen Oral® Saliva Drug Test Pen, CVSHealth® 6 Drugs Oral Test Kit | 2023 | 13 |
| Test, Methamphetamine, Over The Counter | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 16 |
| Test, Opiates, Employment And Insurance Testing, Exempt | Class 2 | Amazewell™ Lollipop Oral Fluid Drug Test, UScreen Oral® Saliva Drug Test Pen, CVSHealth® 6 Drugs Oral Test Kit, Amazewell™ D-Pen™ Oral Fluid Drug Test, MGC Health™ D-PEN™ Oral Fluid Drug Test | 2023 | 12 |
| Test, Opiates, Over The Counter | Class 2 | Fentanyl Urine Test, UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard and 17 more | 2023 | 18 |
| Test, Phencyclidine (Pcp), Over The Counter | Class U | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 12 |
| Test, Propoxyphene, Over The Counter | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 16 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 16 |
| Thin Layer Chromatography, Methamphetamine | Class 2 | UScreen™ Multi-Drug Urine Test Dipcard, Dochek® Multi-Drug Urine Test Dipcard, Amazewell™ Single Drug Urine Test Dipcard, IDT Multi-Drug Urine Test Dipcard, EZCHECK® Multi-Drug Urine Test Dipcard, Amazewell™ Multi-Drug Urine Test Dipcard and 16 more | 2023 | 12 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251040 | 2025-09-09 | LCX | Traditional | This company |
| K250067 | 2025-02-20 | NGL | Traditional | This company |
| K242428 | 2025-02-06 | NGL | Traditional | This company |
| K240643 | 2024-06-21 | LCX | Traditional | This company |
| K240698 | 2024-05-10 | DJG | Traditional | This company |
| K232659 | 2023-12-13 | DJG | Traditional | This company |
| K230038 | 2023-02-28 | LCX | Traditional | This company |
| K222305 | 2022-11-30 | LCX | Traditional | This company |
Nearby Manufacturers
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.