Revogene® GBS LB 410200
GUDID 00628055344117
The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
Meridian Bioscience Canada Inc
Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 00628055344117 |
| NIH Device Record Key | 5fd3d4a7-1099-4d73-994e-d7f56ff62e6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Revogene® GBS LB |
| Version Model Number | 410200 |
| Catalog Number | 410200 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628055344117 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170557
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 | 2019-10-29 |
| Device Publish Date | 2019-10-21 |
Devices Manufactured by Meridian Bioscience Canada Inc
| 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 | 2019-10-29The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. |
| 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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