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| Product | Model | Company | Device type |
|---|---|---|---|
| Aero-MedAero-Med, LLCFaecal specimen collection kit IVD, home-use | AMM18150A | Aero-Med, LLC | Faecal specimen collection kit IVD, home-use |
| AvertD™ (96) AMP MixAutogenomics, IncOpioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) | 03-7560-01 | Autogenomics, Inc | Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) |
| AvertD™ (96) PE MixAutogenomics, IncOpioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) | 03-6560-01 | Autogenomics, Inc | Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) |
| AvertD™ Amplification MixAutogenomics, IncOpioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) | 03-3560-01 | Autogenomics, Inc | Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) |
| AvertD™ Buccal Sample Collection KitAutogenomics, IncOral/upper respiratory tract specimen collection kit IVD, clinical | 12-0610-01 | Autogenomics, Inc | Oral/upper respiratory tract specimen collection kit IVD, clinical |
| AvertD™ Intellipac Reagent ModuleAutogenomics, IncOpioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) | 03-2560-01 | Autogenomics, Inc | Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) |
| BabioJinan Babio Biotechnology Co., Ltd.Cytology specimen container IVD, transport buffer | VTM | Jinan Babio Biotechnology Co., Ltd. | Cytology specimen container IVD, transport buffer |
| BioSciShenzhen Dakewe Bio-engineering Co., LtdGeneral specimen collection kit IVD, clinical | OM | Shenzhen Dakewe Bio-engineering Co., Ltd | General specimen collection kit IVD, clinical |
| Biosci™Shenzhen Dakewe Bio-engineering Co., LtdGeneral tissue specimen container IVD, fixative/saline | MS | Shenzhen Dakewe Bio-engineering Co., Ltd | General tissue specimen container IVD, fixative/saline |
| BioTekeBioteke Corporation (Wuxi) Co., Ltd.General specimen collection kit IVD, clinical | ST7001-2 | Bioteke Corporation (Wuxi) Co., Ltd. | General specimen collection kit IVD, clinical |
| BioTekeBioteke Corporation (Wuxi) Co., Ltd.General specimen collection kit IVD, clinical | ST8001-2 | Bioteke Corporation (Wuxi) Co., Ltd. | General specimen collection kit IVD, clinical |
| eSwab 2mL Reg Flock 500 KT/PKRemel, Inc.General specimen collection kit | R723109 | Remel, Inc. | General specimen collection kit |
| ImmunalysisImmunalysis CorpOral/upper respiratory tract specimen collection kit | QS-0025 | Immunalysis Corp | Oral/upper respiratory tract specimen collection kit |
| Inocu SwabsMicrobiologics Inc.PCR/NAT negative control IVD | MRSA-02 | Microbiologics Inc. | PCR/NAT negative control IVD |
| Mawi DNA TechnologiesMawi Dna Technologies, LLCMolecular grade buffered sample diluent IVD | ISWAB-ID-250 | Mawi Dna Technologies, LLC | Molecular grade buffered sample diluent IVD |
| Molecular Transport Media (MTM) 2mlA. L. B. LuzOral/upper respiratory tract specimen collection kit | MEI00218 | A. L. B. Luz | Oral/upper respiratory tract specimen collection kit |
| Mswab®Copan Italia SpAGeneral specimen collection kit | 404C | Copan Italia SpA | General specimen collection kit |
| Multi-CollectAbbott Molecular Inc.General specimen container IVD, no additive/medium | 9K12-04 | Abbott Molecular Inc. | General specimen container IVD, no additive/medium |
| OMNIgene GUT DxDNA Genotek IncFaecal specimen container IVD, DNA preservation solution | OMD-200 | DNA Genotek Inc | Faecal specimen container IVD, DNA preservation solution |
| ORAcollect DxDNA Genotek IncOral/upper respiratory tract specimen collection swab | OCD-100A | DNA Genotek Inc | Oral/upper respiratory tract specimen collection swab |
| Oragene DxDNA Genotek IncOral/respiratory tract specimen container IVD, additive/medium | OGD-610 | DNA Genotek Inc | Oral/respiratory tract specimen container IVD, additive/medium |
| Oral-EzeCapitol Vial, Inc.Drug-testing specimen collection kit IVD | SA96100 | Capitol Vial, Inc. | Drug-testing specimen collection kit IVD |
| OraSure HIV-1 Oral Specimen Collection DeviceOrasure Technologies, Inc.Oral/upper respiratory tract specimen collection kit | HIV-1 Oral Specimen Collection Device | Orasure Technologies, Inc. | Oral/upper respiratory tract specimen collection kit |
| PAXgene® Blood RNA KitPreAnalytiX GmbHNucleic acid extraction/isolation kit IVD | Version 2 | PreAnalytiX GmbH | Nucleic acid extraction/isolation kit IVD |
| Starswab Anaerobic Transport SystemPretium Canada Packaging ULCGeneral specimen collection kit IVD, clinical | S120-0 | Pretium Canada Packaging ULC | General specimen collection kit IVD, clinical |