The following data is part of a premarket notification filed by Diagenode with the FDA for Panther Fusion Gbs Assay.
| Device ID | K181156 |
| 510k Number | K181156 |
| Device Name: | Panther Fusion GBS Assay |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Applicant | Diagenode Rue Du Bois Saint Jean 3 Seraing, BE 4102 |
| Contact | Geraldine Poncin |
| Correspondent | Jinjie Hu Axteria BioMed Consulting Inc. 8040 Cobble Creek Circle Potomac, MD 20854 |
| Product Code | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2018-07-27 |
| Summary: | summary |