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Revogene® Mock Pie
EUDAMEDFDA UDIFDA 510(k)Class A (EU MDR)
Ref 610208510(k) K243922
Identity
- Trade Name
- Revogene® Mock Pie EUDAMEDRevogene Mock Pie FDA UDI
- Generic Name
- Centrifuge tube counterbalance FDA UDI
- Device Name
- Revogene® Mock Pie EUDAMEDThe MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene instrument and the Revogene assays. The MOCK Pie simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run. FDA UDI
- Model / Reference
- 610208 EUDAMEDFDA UDI
- Description
- The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene instrument and the Revogene assays. The MOCK Pie simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run. FDA UDI
Identifiers
- Catalog Number
- 610208 FDA UDI
- Primary DI / UDI-DI
- 00840733102332 EUDAMEDFDA UDI
- Basic UDI-DI
- 008407331REVOGENECLA003TK EUDAMED
- Direct Marketing DI
- 00840733102332 EUDAMED
- FDA Product Code
- OOI FDA UDI
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES EUDAMED
- GMDN Term
- Centrifuge tube counterbalance FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Revogene® Mock Pie by Meridian Bioscience Inc. — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220480 | Class A | Active |
| FDA 510(k) | United States | FDA_510K | K222779 | Class A | Active |
| FDA 510(k) | United States | FDA_510K | K243922 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 008407331REVOGENECLA003TK | Class A | Active |
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Manufacturer
- Manufacturer
- Meridian Bioscience Inc.
- EUDAMED SRN
- US-MF-000044096
- FDA Applicant
- Meridian Bioscience, Inc.
- Authorised Representative
- Meridian Bioscience Europe S.r.l. IT-AR-000010460
Sources (3)
- EUDAMED 95a554bd-104c-431d-867e-4f8208286304 85 fields · synced Jun 18, 2026
- FDA UDI 01068da0-2b69-455e-af4c-30ba6b663165 36 fields · synced May 30, 2026
- FDA 510(k) K220480 1 fields · synced May 18, 2026