The following data is part of a premarket notification filed by Great Basin Corporation with the FDA for Portrait Gbs Assay.
| Device ID | K143312 |
| 510k Number | K143312 |
| Device Name: | Portrait GBS Assay |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Applicant | GREAT BASIN CORPORATION 2441 SOUTH 3850 WEST Salt Lake City, UT 84120 |
| Contact | Chuck Owen |
| Correspondent | Chuck Owen GREAT BASIN CORPORATION 2441 SOUTH 3850 WEST Salt Lake City, UT 84120 |
| Product Code | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-18 |
| Decision Date | 2015-04-21 |