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| Product | Model | Company | Device type |
|---|---|---|---|
| cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) | 09857664190 | Roche Molecular Systems, Inc. | Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) |
| cobas® Liat® Strep A ScriptRoche Molecular Systems, Inc.Laboratory instrument/analyser application software IVD | 08085471001 | Roche Molecular Systems, Inc. | Laboratory instrument/analyser application software IVD |
| cobas® Strep A Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc.Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) | 07341911190 | Roche Molecular Systems, Inc. | Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) |
| Simplexa™ Group A Strep Positive Control PackDiasorin Molecular LLCBeta-haemolytic Group A Streptococcus nucleic acid IVD, control | MOL2860 | Diasorin Molecular LLC | Beta-haemolytic Group A Streptococcus nucleic acid IVD, control |
| SolanaDiagnostic Hybrids, Inc.Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT) | M305 | Diagnostic Hybrids, Inc. | Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT) |
| SolanaDiagnostic Hybrids, Inc.Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT) | M308 | Diagnostic Hybrids, Inc. | Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT) |
| Xpert Xpress Strep ACepheidBeta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) | XPRSTREPA-10 | Cepheid | Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) |