| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | Cepheid |
| K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | DiaSorin Molecular LLC |
| K181156 | Panther Fusion GBS Assay | Diagenode |
| K173725 | NeuMoDx GBS Assay | NeuMoDx Molecular, Inc. |
| K173250 | Solana GBS Assay | Quidel Corporation |
| K170557 | GenePOC GBS LB | GenePOC Inc. |
| K162772 | ARIES GBS Assay | LUMINEX CORPORATION |
| K143312 | Portrait GBS Assay | GREAT BASIN CORPORATION |
| K133503 | AMPLIVUE GBS ASSAY | QUIDEL CORPORATION |
| K121539 | XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) | CEPHEID |
| K121044 | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM | MERIDIAN BIOSCIENCE, INC. |
| K112125 | ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT | MERIDIAN BIOSCIENCE, INC. |
| K111860 | BD MAX GBS ASSAY, BD MAX INSTRUMENT | BECTON DICKINSON & CO. |
| K090191 | HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB | HANDYLAB, INC |
| K062948 | SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B | CEPHEID |
| 00382904417727 | Nucleic acid amplification assay system, group b streptococcus, direct specimen test |
| 00628055344018 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004910 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004903 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004880 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004866 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004842 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004835 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004804 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004798 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004767 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004743 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004606 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004583 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 07332940004569 | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |