| Primary Device ID | B178GBCDIFF100 |
| NIH Device Record Key | e9e7e8d7-7858-4547-96d9-9009bcb4e1ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Portrait Toxigenic C. difficile Assay |
| Version Model Number | GBCDIFF-10 |
| Catalog Number | GBCDIFF-10 |
| Company DUNS | 827115259 |
| Company Name | GREAT BASIN SCIENTIFIC, 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 | 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 |
| Phone | (888) 333-9763 |
| customersupport@gbscience.com | |
| Phone | (888) 333-9763 |
| customersupport@gbscience.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B178GBCDIFF100 [Primary] |
| HIBCC | B178GBCDIFF102 [Package] Package: Box [10 Units] In Commercial Distribution |
| OZN | C.Difficile Toxin Gene Amplification Assay |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
| B178GBSIDR102 - Staph ID/R Blood Culture Panel | 2019-01-23 |
| B178GBBORD100 - Bordetella Direct Test | 2018-03-29 Bordetella Direct Test Cartridge |
| B178GBCDIFF100 - Portrait Toxigenic C. difficile Assay | 2018-03-29C. diff Assay Cartridge and Sample Prep Device. |
| B178GBCDIFF100 - Portrait Toxigenic C. difficile Assay | 2018-03-29 C. diff Assay Cartridge and Sample Prep Device. |
| B178GBGBS100 - Group B Strep Assay | 2018-03-29 |
| B178SBPP102 - Stool Bacterial Pathogens Panel | 2018-03-29 Stool Bacterial Pathogens Panel Cartridge with sample prep device. |
| B178GBSTEC102 - Shiga Toxin Direct Test | 2018-03-29 Shiga Toxin Direct Test Cartridge with sample prep device. |
| B178PA5000 - PA500 Portrait Analyzer | 2018-03-29 |