Hangzhou AllTest Biotech Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 48 device types, 235 products catalogued, 14 clearances.
Hangzhou AllTest Biotech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Paper, Obstetric Ph, Test, Urine Leukocyte and 46 other device types. 224 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
48device types registered with the FDA
235products catalogued under its own name
14510(k) clearances
Registration
| Registered name | Hangzhou AllTest Biotech Co.,Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3043127647 |
| FEI number | 3043127647 |
| DUNS | 543254717 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 杭州奥泰生物技术股份有限公司 |
|---|---|
| Unified social credit code | 91330101685842840Y |
| Source | NMPA UDI database |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | No.616 Dongwei Road, Qiantang District |
| Postal code | 311222 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Antigens, All Groups, Streptococcus Spp. | Class 1 | AllTest Strep A Rapid Test | 2026 | 6 |
| Culture Media, Non-Propagating Transport | Class 1 | AllTest Viral Transport Medium, ACRO Viral Transport Medium, Atida Viral Transport Medium, Citest Viral Transport Medium | 2025 | 11 |
| Devices, Breath Trapping, Alcohol | Class 1 | WorkCHEK Breath Alcohol Test, For employment and insurance use | 2024 | 16 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class 1 | Vivoo At-Home UTI Test Strips, Berkeley health Urinary Tract Infections Rapid Test, 2San UTI Test, Citest Urinary Tract Infection Test, Rapid Response Urinary Tract infection Screen Strips, Mobilab Urinary Tract Infection Test and 6 more | 2025 | 14 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | Class 1 | Certum Adulteration Dipstick, Adulteration Dipstick | 2017 | 16 |
| Enzyme Immunoassay, Amphetamine | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 71 more | 2019 | 16 |
| Enzyme Immunoassay, Barbiturate | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 72 more | 2019 | 12 |
| Enzyme Immunoassay, Benzodiazepine | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 72 more | 2019 | 13 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 71 more | 2019 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 71 more | 2019 | 16 |
| Enzyme Immunoassay, Methadone | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 72 more | 2019 | 11 |
| Enzyme Immunoassay, Opiates | Class 2 | Identify Health Fentanyl Urine Test Cassette, Discover Fentanyl Rapid Test Cassette, Atida Fentanyl Drug of Abuse Test, CLIAwaived, Inc. Rapid Drug Test Device“RDTD”for Fentanyl in Urine, One Step Fentanyl Urine Test Cassette, GenaCheck Fentanyl Urine Test Cassette and 103 more | 2019 | 17 |
| Enzyme Immunoassay, Phencyclidine | Class U | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 71 more | 2019 | 16 |
| Gas Chromatography, Methamphetamine | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 71 more | 2019 | 10 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | ALLTEST hCG Early Pregnancy Rapid Test, getTested Early Pregnancy Test, PHAMATECH QUICKSTICK Early Pregnancy Test, One Step hCG Early Rapid Pregnancy Test Midstream, Citest Early Pregnancy Home Test, ACESO Early Pregnancy Test and 30 more | 2018 | 30 |
| Paper, Obstetric Ph | Class 1 | BERKELEY HEALTH Vaginal pH Test, Vaginal pH Rapid Test | 2026 | 13 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | Class 2 | THYROCHEK Thyroid Test Rapid TSH Cassette (Whole Blood), CLIAwaived Inc. Thyroid Test Rapid TSH Cassette (Whole Blood) | 2019 | 2 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 71 more | 2019 | 9 |
| Test System, Nicotine, Cotinine, Metabolites | Class 1 | iSCREEN™ ORAL FLUID DRUG TEST(product code: ABTDCTCUBO0102), Cotinine (COT) Rapid Test Cassette Oral Fluid, Cotinine (COT) Rapid Test Panel Powder, Cotinine (COT) Rapid Test | 2017 | 11 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | Class 2 | AMPHETAMINE(AMP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT | 2017 | 11 |
| Test, Amphetamine, Over The Counter | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 143 more | 2019 | 16 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | Class 2 | Barbiturate(BAR) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT | 2017 | 11 |
| Test, Barbiturate, Over The Counter | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 143 more | 2019 | 16 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | Class 2 | Benzodiazepines(BZO) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT | 2017 | 11 |
| Test, Benzodiazepine, Over The Counter | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 143 more | 2019 | 16 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | Class 2 | Marijuana(THC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT | 2017 | 12 |
| Test, Cannabinoid, Over The Counter | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 143 more | 2019 | 16 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | Class 2 | Cocaine(COC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT | 2017 | 12 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 143 more | 2019 | 16 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | One Step FSH Urine test strip, One Step FSH Urine midstream Test, QuickScreen At Home FSH/Menopause Rapid Test (Urine), BERKELEY HEALTH Menopause FSH Test, FSH Rapid Test Dipstick, FSH Rapid Test Midstream and 1 more | 2017 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Ovulation (LH) Rapid Test Midstream, Ovulation (LH) Rapid Test Cassette, Ovulation (LH) Rapid Test Dipstick, QuickScreen At Home Digital Ovulation Test, Digital LH Ovulation Test Strip, BERKELEY HEALTH Ovulation LH Test | 2024 | 38 |
| Test, Methadone, Employment And Insurance Testing, Exempt | Class 2 | Methadone(MTD) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT | 2017 | 11 |
| Test, Methadone, Over The Counter | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 143 more | 2019 | 17 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | Class 2 | Methamphetamine(MET) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT, Drink Check Test | 2017 | 13 |
| Test, Methamphetamine, Over The Counter | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 143 more | 2019 | 16 |
| Test, Methaqualone, Employment And Insurance Testing, Exempt | Class 2 | Methaqualone(MQL) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT | 2017 | 6 |
| Test, Morphine, Employment And Insurance Testing, Exempt | Class 2 | Morphine(MOP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT | 2017 | 8 |
| Test, Morphine, Over The Counter | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 96 more | 2019 | 4 |
| Test, Opiates, Employment And Insurance Testing, Exempt | Class 2 | Opiates(OPI) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT | 2017 | 12 |
| Test, Opiates, Over The Counter | Class 2 | Identify Health Fentanyl Urine Test Cassette, Discover Fentanyl Rapid Test Cassette, Atida Fentanyl Drug of Abuse Test, CLIAwaived, Inc. Rapid Drug Test Device“RDTD”for Fentanyl in Urine, One Step Fentanyl Urine Test Cassette, GenaCheck Fentanyl Urine Test Cassette and 168 more | 2019 | 18 |
| Test, Phencyclidine (Pcp), Over The Counter | Class U | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 143 more | 2019 | 12 |
| Test, Propoxyphene, Employment And Insurance Testing, Exempt | Class 2 | Propoxyphene(PPX) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT | 2017 | 7 |
| Test, Propoxyphene, Over The Counter | Class 2 | AllTest Multi-Drug Urine Test Cup, DrugTect Multi-Drug Rapid Urine Test Cup, Identify Health Multi-Drug Urine Test Cup, AllTest Multi-Drug Rapid Urine Test Cup, Atida Multiplex Drug of Abuse Rapid Urine Cup Test, CHOSEN Multi-Drug Rapid Urine Test Cup and 42 more | 2025 | 16 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 143 more | 2019 | 16 |
| Test, Urine Leukocyte | Class 1 | Vivoo At-Home UTI Test Strips, Berkeley health Urinary Tract Infections Rapid Test, 2San UTI Test, Citest Urinary Tract Infection Test, Rapid Response Urinary Tract infection Screen Strips, Mobilab Urinary Tract Infection Test and 6 more | 2025 | 16 |
| Thin Layer Chromatography, Methamphetamine | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 71 more | 2019 | 12 |
| Thin Layer Chromatography, Morphine | Class 2 | ACRO Single Drug Test Strip, Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine), Rapid Response Drug Screening Test Strip- OTC (Urine), One Step Ecstasy (MDMA) Urine Test Strip, VeriCheck Drug Test Dip (Urine), L-Cup Home Rapid Test (Urine) and 71 more | 2019 | 4 |
| Visual, Pregnancy Hcg, Prescription Use | Class 2 | Alltest Pregnancy Rapid Combo Test Cassette, Medline hCG Combo Pregnancy Test Cassette, CLARITY hCG Combo Cassette, Citest hCG Pregnancy Combo Rapid Test, ACRO hCG Pregnancy Combo Test, Identify Health Pregnancy Rapid Combo Test Cassette and 2 more | 2022 | 16 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260342 | 2026-04-30 | GTY | Traditional | This company |
| K252607 | 2025-10-30 | JMT | Traditional | This company |
| K251053 | 2025-07-15 | LCX | Traditional | This company |
| K250727 | 2025-04-04 | NFT | Traditional | This company |
| K242576 | 2025-04-04 | JSM | Traditional | This company |
| K244043 | 2025-02-27 | NFT | Traditional | This company |
| K242540 | 2024-09-27 | NFT | Traditional | This company |
| K241978 | 2024-08-13 | LCX | Traditional | This company |
| K241428 | 2024-06-17 | NFT | Traditional | This company |
| K233019 | 2023-12-13 | DKZ | Traditional | This company |
| K233417 | 2023-10-26 | NGL | Traditional | This company |
| K231698 | 2023-07-31 | DJG | Traditional | This company |
| K203272 | 2022-01-31 | JHI | Traditional | This company |
| K182738 | 2019-03-27 | DKZ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Employees | 201-500 |
| Main products | COVID-19 diagnostics, Rapid tests, LF reader, Veterinary diagnostics, Fluorescence testing |
| Certifications | CE, ISO |
| Export markets | 100+ countries |
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.
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