Data / Medical devices / United States / R-Biopharm Clinical USA Inc.
R-Biopharm Clinical USA Inc.: FDA-registered device maker in Washington, MO, United States, 2 510(k) clearances
R-Biopharm Clinical USA Inc. is registered with the FDA (registration 3016548670) in Washington, MO, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 21, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3016548670
- Address
- 870 Vossbrink Dr, Washington, MO, United States, 63090
- Owner or operator
- R-Biopharm Clinical USA Inc. (10088745)
- Roles
- Complaint file establishment
- First device listed
- October 19, 2023
- Registered through
- 2026
- Brand names listed
- RIDASCREEN® Pancreatic Elastase ELISA, RIDA® CCD-Inhibitor, RIDA®GENE Norovirus GI/GII
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Norovirus Serological Reagent | OUC | 2 | Complaint file establishment | accessdata.fda.gov |
| P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | JNN | 1 | Complaint file establishment | accessdata.fda.gov |
| Protein, Complement, Antigen, Antiserum, Control | DHL | 1 | Complaint file establishment | accessdata.fda.gov |
| Reagents For Detection Of Norovirus Nucleic Acid | PIQ | 2 | Complaint file establishment | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2017 | K171511 | RIDA GENE Norovirus GI/GII | PIQ | Substantially Equivalent | R-Biopharm AG | accessdata.fda.gov |
| February 23, 2011 | DEN110001 | RIDASCREEN NOROVIRUS 3RD GENERATION EIA | OUC | Unknown | R-Biopharm AG | accessdata.fda.gov |
Compare with other makers
- All makers of Real Time Nucleic Acid Amplification System
- All makers of Norovirus Serological Reagent
- All makers of P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin
Updated August 21, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.