Data / Medical devices / Germany / R-Biopharm AG
R-Biopharm AG: FDA-registered device maker in DARMSTADT Hesse, Germany, 1 510(k) clearance
R-Biopharm AG is registered with the FDA (registration 3004061467) in DARMSTADT Hesse, Germany. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 21, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004061467
- Address
- An der neuen Bergstrasse 17, DARMSTADT Hesse, Germany, D-64297
- Owner or operator
- R-BIOPHARM AG (9058209)
- Roles
- Manufacturer
- First device listed
- September 28, 2017
- 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 |
|---|---|---|---|---|
| P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | JNN | 1 | Manufacturer | accessdata.fda.gov |
| Protein, Complement, Antigen, Antiserum, Control | DHL | 1 | Manufacturer | accessdata.fda.gov |
| Reagents For Detection Of Norovirus Nucleic Acid | PIQ | 2 | Manufacturer | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Manufacturer | 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 |
Compare with other makers
- All makers of Real Time Nucleic Acid Amplification System
- 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.