| Primary Device ID | 00628055344032 |
| NIH Device Record Key | e010adfd-9e6d-438e-8450-6c720d70c4c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MOCK PIE |
| Version Model Number | 132331 |
| Catalog Number | 132331 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com | |
| Phone | 1-844-616-1544 |
| fran@mdcassoc.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628055344032 [Primary] |
| OOI | Real Time Nucleic Acid Amplification System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-12-29 |
| 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 | 2018-07-06The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower then eight in a run. |
| 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 |