Shanghai Venture Bio-Tech Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 2
What Shanghai Venture Bio-Tech Co., Ltd. makes
The company manufactures rapid lateral flow test cassettes and test cups for detecting specific drugs of abuse, including amphetamines, cocaine, methamphetamine, morphine, marijuana, and oxazepam. These products are designed for over-the-counter (OTC) and prescription (Rx) use, providing qualitative results for point-of-care testing.
The portfolio consists of Class II medical devices, authorised via the FDA’s 510(k) pathway. These products are listed under the US regulatory framework and are intended for drug testing applications.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Shanghai Venture Bio-Tech Co., Ltd. have in the registry?
The registry currently lists 2 devices for Shanghai Venture Bio-Tech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shanghai Venture Bio-Tech Co., Ltd.'s devices?
Among its 2 most recently registered devices, Shanghai Venture Bio-Tech Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Shanghai Venture Bio-Tech Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Shanghai Venture Bio-Tech Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shanghai Venture Bio-Tech Co., Ltd. in the registry?
The most recently registered devices listed for Shanghai Venture Bio-Tech Co., Ltd. include BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx and BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use.