Yamasa Shoy Co., Ltd.
JapanFDA 510(k) applicant, unverified
- Devices
- 2
What Yamasa Shoy Co., Ltd. makes
Yamasa Shoy Co., Ltd. manufactures enzyme immunoassay (EIA) test kits for detecting human vanillylmandelic acid (HVA) and vanillylmandelic acid (VMA) in urine samples. These kits are designed for clinical laboratory use to aid in the diagnosis of neuroendocrine tumors and related conditions.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed via the 510(k) pathway. The devices are registered in the United States, where the manufacturer is based.
Catalogue
Hva Eia Kit Yamasa Ref K895288
510(k) 510(k)Vma Eia Kit Yamasa Ref K895287
510(k) 510(k)
Frequently asked questions
How many devices does Yamasa Shoy Co., Ltd. have in the registry?
The registry currently lists 2 devices for Yamasa Shoy Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Yamasa Shoy Co., Ltd.'s devices?
Among its 2 most recently registered devices, Yamasa Shoy Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Yamasa Shoy Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Yamasa Shoy Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Yamasa Shoy Co., Ltd. in the registry?
The most recently registered devices listed for Yamasa Shoy Co., Ltd. include HVA EIA KIT YAMASA and VMA EIA KIT YAMASA.