← Back to catalogue

Revogene®

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 610210

by Meridian Bioscience Inc.

Identity

Trade Name
Revogene® EUDAMED
Revogene FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Device Name
Revogene® EUDAMED
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes. FDA UDI
Model / Reference
610210 EUDAMEDFDA UDI
Description
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes. FDA UDI

Identifiers

Catalog Number
610210 FDA UDI
Primary DI / UDI-DI
00840733102318 EUDAMEDFDA UDI
Basic UDI-DI
008407331REVOGENECLA001TF EUDAMED
Direct Marketing DI
00840733102318 EUDAMED
510(k) Number
K170558 FDA UDI
K220480 FDA UDI
K222779 FDA UDI
FDA Product Code
OOI FDA UDI
EMDN Code
W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI

Classification

Device Class
Class A EUDAMED
Class 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

Yes

EUDAMED

New Device

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nucleic acid sample preparation instrument IVD

Revogene® by Meridian Bioscience, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid sample preparation instrument IVD.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Meridian Bioscience Inc.
EUDAMED SRN
US-MF-000044096
Authorised Representative
Meridian Bioscience Europe S.r.l. IT-AR-000010460

Sources (2)

  • EUDAMED 5b88d754-4ae4-42d1-a83b-cb229954ffd7 61 fields · synced May 31, 2026
  • FDA UDI 20c66b24-da19-4cab-928e-d01d111b52c9 37 fields · synced May 30, 2026