GenePOC™ Carba 133499
GUDID 00628055344070
The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR). The GenePOC Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC Carba assay result does not preclude the presence of other resistance mechanisms. The GenePOC Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.
GenePoc Inc
Multiple antimicrobial resistance nucleic acid IVD, nucleic acid technique (NAT)| Primary Device ID | 00628055344070 |
| NIH Device Record Key | fc3e06e4-c343-45b6-9e06-7c8deb8a3b3d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GenePOC™ Carba |
| Version Model Number | 133499 |
| Catalog Number | 133499 |
| Company DUNS | 202672846 |
| Company Name | GenePoc 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
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca | |
| Phone | 1-844-616-1544 |
| service@genepoc.ca |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628055344070 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190275
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 | 2019-06-03 |
| Device Publish Date | 2019-05-24 |
Devices Manufactured by GenePoc Inc
| 00628055344070 - GenePOC™ Carba | 2019-06-03The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR). The GenePOC Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC Carba assay result does not preclude the presence of other resistance mechanisms. The GenePOC Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections. |
| 00628055344070 - GenePOC™ Carba | 2019-06-03 The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the |
| 00628055344087 - GenePOC™ Strep A | 2019-05-08 The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that util |
| 00628055344001 - revogene™ | 2018-07-06 The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assa |
| 00628055344018 - GenePOC™ GBS LB | 2018-07-06 The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test designed to detect |
| 00628055344025 - GenePOC™ CDiff | 2018-07-06 The GenePOC™ CDiff assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test that utilizes autom |
| 00628055344032 - MOCK PIE | 2018-07-06 The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE |
Trademark Results [GenePOC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENEPOC 85645608 5688411 Live/Registered |
Genepoc Inc. 2012-06-07 |
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