Revogene® 610210
GUDID 00628055344100
The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. The Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real time PCR.
Meridian Bioscience Canada Inc
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated| Primary Device ID | 00628055344100 |
| NIH Device Record Key | a3fadb70-b0c5-4cd5-91a8-5a31a3400eea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Revogene® |
| Version Model Number | 610210 |
| Catalog Number | 610210 |
| Company DUNS | 204006360 |
| Company Name | Meridian Bioscience Canada Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628055344100 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170558
FDA Product Code
| OOI | Real Time Nucleic Acid Amplification System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-11 |
| Device Publish Date | 2019-11-01 |
Devices Manufactured by Meridian Bioscience Canada Inc
| 00628055344100 - Revogene® | 2019-11-11The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. The Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real time PCR. |
| 00628055344100 - Revogene® | 2019-11-11 The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assay |
| 00628055344117 - Revogene® GBS LB | 2019-10-29 The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Gr |
| 00628055344124 - Revogene® C. difficile | 2019-10-29 The Revogene® C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes a |
| 00628055344131 - MOCK PIE | 2019-10-29 The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene® instrument and Revogene® assays. The MOCK P |
| 00628055344162 - Revogene® Carba C | 2019-10-29 The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualitative in vitro diagnostic test designed for the |
| 00628055344179 - Revogene® Strep A | 2019-10-29 The Revogene® Strep A assay, performed on the Revogene® instrument, is an automated, qualitative in vitro diagnostic test that |
Trademark Results [Revogene]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVOGENE 87514391 5784546 Live/Registered |
Genepoc Inc. 2017-07-03 |
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