Vivachek Biotech (Hangzhou) Co., Ltd.
Registered establishment in Hangzhou, Zhuji, Zhejiang, China. 21 device types, 10 clearances.
Vivachek Biotech (Hangzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Glucose Oxidase, Glucose, Enzyme Immunoassay, Opiates and 19 other device types. Its earliest product listing with the FDA dates from 2017.
21device types registered with the FDA
10510(k) clearances
Registration
| Registered name | VIVACHEK BIOTECH (HANGZHOU) CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013223546 |
| FEI number | 3013223546 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 杭州微策生物技术股份有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou, Zhuji |
|---|---|
| Province | Zhejiang |
| Address | No.17 Wuzhou Road, Donghu Street, Linping District, Hangzhou, 311100 |
| Postal code | 311100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Device, Cystometric, Hydraulic | Class 2 | 2024 | 3 | |
| Enzyme Immunoassay, Opiates | Class 2 | 2024 | 17 | |
| Enzyme Immunoassay, Phencyclidine | Class U | VivaGuard Multi-Drug Urine Test Cup Rx, VivaGuard Multi-Drug Urine Test Cup | 2022 | 16 |
| Fluorometer, For Clinical Use | Class 1 | VivaDiag POCT Multifunction Meter, VivaDiag Fentanyl Test Kit (FIA), VivaDiag POCT Analyzer (Models: VIM1000; VIM2000; VIM3000) | 2024 | 5 |
| Glucose Oxidase, Glucose | Class 2 | 2017 | 8 | |
| Multiple Use Blood Lancet For Single Patient Use Only | Class 2 | 2022 | 21 | |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | Class 1 | 2020 | 17 | |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | Class 1 | 2017 | 12 | |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class 2 | 2022 | 21 | |
| System, Test, Blood Glucose, Over The Counter | Class 2 | VivaGuard Fad Blood Glucose Monitoring System, VivaGuard Ino Sound Simple Blood Glucose Monitoring System, VivaGuard Ino BLOOD GLUCOSE TEST STRIPS | 2017 | 20 |
| Test, Amphetamine, Over The Counter | Class 2 | VivaGuard Multi-Drug Urine Test Cup Rx, VivaGuard Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Barbiturate, Over The Counter | Class 2 | VivaGuard Multi-Drug Urine Test Cup Rx, VivaGuard Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Benzodiazepine, Over The Counter | Class 2 | VivaGuard Multi-Drug Urine Test Cup Rx, VivaGuard Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Cannabinoid, Over The Counter | Class 2 | VivaGuard Multi-Drug Urine Test Cup Rx, VivaGuard Multi-Drug Urine Test Cup, VivaDiag Marijuana (THC) Rapid Test | 2022 | 16 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | VivaGuard Multi-Drug Urine Test Cup Rx, VivaGuard Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Methadone, Over The Counter | Class 2 | VivaGuard Multi-Drug Urine Test Cup Rx, VivaGuard Multi-Drug Urine Test Cup | 2022 | 17 |
| Test, Methamphetamine, Over The Counter | Class 2 | VivaGuard Multi-Drug Urine Test Cup Rx, VivaGuard Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Opiates, Over The Counter | Class 2 | VivaDiag POCT Multifunction Meter, VivaDiag Fentanyl Test Kit (FIA), VivaGuard Multi-Drug Urine Test Cup Rx, VivaGuard Multi-Drug Urine Test Cup | 2022 | 18 |
| Test, Phencyclidine (Pcp), Over The Counter | Class U | 2025 | 12 | |
| Test, Propoxyphene, Over The Counter | Class 2 | VivaGuard Multi-Drug Urine Test Cup Rx, VivaGuard Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | VivaGuard Multi-Drug Urine Test Cup Rx, VivaGuard Multi-Drug Urine Test Cup | 2022 | 16 |
Clearances
10 clearances name Vivachek Biotech (Hangzhou) Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K261280 | 2026-05-22 | NFT | Traditional | This company |
| K252554 | 2025-09-12 | NFT | Traditional | This company |
| K241869 | 2024-10-04 | NGL | Traditional | This company |
| K222126 | 2024-08-16 | NBW | Traditional | This company |
| K240124 | 2024-06-14 | DJG | Traditional | This company |
| K233058 | 2023-12-22 | NBW | Traditional | This company |
| K233062 | 2023-11-02 | NFT | Traditional | This company |
| K231978 | 2023-08-31 | NFW | Traditional | This company |
| K222667 | 2022-11-10 | NFT | Traditional | This company |
| K192957 | 2020-06-05 | JIN | Traditional | This company |
| K220475 | 2022-07-06 | QRL | Traditional | Tianjin Huahong Technology Co., Ltd. |
| K173140 | 2018-12-19 | NBW | Traditional | Vivachek Laboratories, Inc. |
| K160179 | 2017-04-21 | NBW | Traditional | Vivachek Laboratories, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | Blood glucose analyzers, Blood ketone analyzers, Uric acid analyzers, Immunoassay analyzers, Occult blood test kits |
| Certifications | National-level specialized and innovative enterprise, Provincial-level research institute |
| Export markets | International markets |
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.