Identity
- Trade Name
- RENINE III GENERATION EUDAMEDACTIVE RENIN FDA UDI
- Generic Name
- Renin IVD, kit, radioimmunoassay FDA UDI
- Device Name
- RENINE EUDAMEDRadioimmunometric assay kit for the quantitative determination of active renin in human plasma. Contains enough reagents for 100 tests. For in vitro diagnostic. Quantitative determination of active renin is used in the diagnostic and treatment of certain types of hypertensions. FDA UDI
- Model / Reference
- RENINE EUDAMEDRENIN FDA UDI
- Description
- Radioimmunometric assay kit for the quantitative determination of active renin in human plasma. Contains enough reagents for 100 tests. For in vitro diagnostic. Quantitative determination of active renin is used in the diagnostic and treatment of certain types of hypertensions. FDA UDI
Identifiers
- Catalog Number
- RENIN FDA UDI
- Primary DI / UDI-DI
- 03770024321319 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03770024321319 EUDAMED
- 510(k) Number
- K062120 FDA UDI
- FDA Product Code
- CIB FDA UDI
- EMDN Code
- W0102060206 RENINE DIRECT EUDAMED
- GMDN Term
- Renin IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1085 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Renine Iii Generation by Cisbio Bioassays — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-03770024321319 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Cisbio Bioassays
- EUDAMED SRN
- FR-MF-000024051
Sources (2)
- EUDAMED 03d211da-854d-4aee-b856-5b456498a468 61 fields · synced Jul 11, 2026
- FDA UDI 84baa21b-3db3-4d1d-8c19-81b0bb0ae26a 38 fields · synced May 30, 2026