Runbio Biotech Co., Ltd
Country not established
- Devices
- 3
What Runbio Biotech Co., Ltd makes
Runbio Biotech Co., Ltd manufactures lateral flow immunoassay devices for home and professional use, including pregnancy test cassettes and strips. Products include midstream urine tests for home use, as well as prescription-only versions for clinical settings. The portfolio covers both single-use and cassette-style formats for detecting human chorionic gonadotropin (hCG).
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database. Runbio Biotech Co., Ltd is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
David Pregnancy Test (Midstream) Ref K053236
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Runbio Biotech Co., Ltd have in the registry?
The registry currently lists 3 devices for Runbio Biotech Co., Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Runbio Biotech Co., Ltd's devices?
Among its 3 most recently registered devices, Runbio Biotech Co., Ltd has devices listed in FDA 510(k) (3 devices).
What risk classes do Runbio Biotech Co., Ltd's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Runbio Biotech Co., Ltd's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Runbio Biotech Co., Ltd in the registry?
The most recently registered devices listed for Runbio Biotech Co., Ltd include David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette, DAVID PREGNANCY TEST (MIDSTREAM) and DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette.