Identity
- Trade Name
- Revogene® Check EUDAMEDRevogene Check FDA UDI
- Generic Name
- Thermal cycler nucleic acid instrument calibrator/control kit IVD FDA UDI
- Device Name
- Revogene® Check EUDAMEDThe Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm that the optical and thermal parameters of the Revogene Instrument are within specifications. It is intended for use by qualified laboratory personnel who have been trained and are proficient in performing testing on the Revogene instrument or by Meridian Bioscience service personnel. FDA UDI
- Model / Reference
- 610220 EUDAMEDFDA UDI
- Description
- The Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm that the optical and thermal parameters of the Revogene Instrument are within specifications. It is intended for use by qualified laboratory personnel who have been trained and are proficient in performing testing on the Revogene instrument or by Meridian Bioscience service personnel. FDA UDI
Identifiers
- Catalog Number
- 610220 FDA UDI
- Primary DI / UDI-DI
- 00840733103285 EUDAMEDFDA UDI
- Basic UDI-DI
- 008407331REVOGENECLA002TH EUDAMED
- Direct Marketing DI
- 00840733103285 EUDAMED
- FDA Product Code
- OHQ FDA UDI
- EMDN Code
- W0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMED
- GMDN Term
- Thermal cycler nucleic acid instrument calibrator/control kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Italy 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
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
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
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Revogene® Check by Meridian Bioscience Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 008407331REVOGENECLA002TH | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience Inc.
- EUDAMED SRN
- US-MF-000044096
- Authorised Representative
- Meridian Bioscience Europe S.r.l. IT-AR-000010460
Sources (2)
- EUDAMED d6f8318a-7e10-4b4b-848a-c9495c2475a4 61 fields · synced Jul 11, 2026
- FDA UDI b8b48498-2d0b-41dc-830a-28fed6ef0a93 36 fields · synced May 30, 2026