| ACCESS HIV Ag/Ab comboBeckman Coulter, Inc.HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay | C39450 | Beckman Coulter, Inc. | HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay |
| ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mLLgc Clinical Diagnostics, Inc.Hepatitis B virus antigen/antibody marker IVD, control | 2000-0065 | Lgc Clinical Diagnostics, Inc. | Hepatitis B virus antigen/antibody marker IVD, control |
| ACCURUN®Lgc Clinical Diagnostics, Inc.HIV1 antigen IVD, control | 2015-0066 | Lgc Clinical Diagnostics, Inc. | HIV1 antigen IVD, control |
| AcroMetrix BB NAT HCV Positive ControlMicrogenics CorporationHepatitis C virus antibody/antigen IVD, control | 963601 | Microgenics Corporation | Hepatitis C virus antibody/antigen IVD, control |
| AlinityAbbott GmbHHIV1/HIV2 antigen/antibody IVD, calibrator | 08P0702 | Abbott GmbH | HIV1/HIV2 antigen/antibody IVD, calibrator |
| AlinityAbbott GmbHLaboratory instrument/analyser application software IVD | 06P015A | Abbott GmbH | Laboratory instrument/analyser application software IVD |
| AmpliPROBEBio-Rad Laboratories, Inc.Multiple-type sexually transmitted pathogen nucleic acid IVD, control | 00138 | Bio-Rad Laboratories, Inc. | Multiple-type sexually transmitted pathogen nucleic acid IVD, control |
| Elecsys HIV combi PTRoche Diagnostics GmbHHIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay | 08924180160 | Roche Diagnostics GmbH | HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay |
| Express HIV-1 Test SystemHome Access Health CorporationCapillary blood collection set, home-use | 20 | Home Access Health Corporation | Capillary blood collection set, home-use |
| GeeniusBio-RAD Laboratories, Inc.HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay | 72480 | Bio-RAD Laboratories, Inc. | HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay |
| GSBio-RAD Laboratories, Inc.HIV1 antibody IVD, kit, immunoblot | 32508 | Bio-RAD Laboratories, Inc. | HIV1 antibody IVD, kit, immunoblot |
| GSBio-RAD Laboratories, Inc.HIV1 antibody IVD, kit, immunoblot | 25062C | Bio-RAD Laboratories, Inc. | HIV1 antibody IVD, kit, immunoblot |
| GSBio-RAD Laboratories, Inc.HIV1 antibody IVD, kit, immunoblot | 12000085 | Bio-RAD Laboratories, Inc. | HIV1 antibody IVD, kit, immunoblot |
| HIV-1 Standard Test SystemHome Access Health CorporationCapillary blood collection set, home-use | 21 | Home Access Health Corporation | Capillary blood collection set, home-use |
| MP Diagnostics HTLV Blot 2.4Mp Biomedicals Asia Pacific Pte. Ltd.Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot | 18 test | Mp Biomedicals Asia Pacific Pte. Ltd. | Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot |
| MP Diagnostics HTLV Blot 2.4Mp Biomedicals Asia Pacific Pte. Ltd.Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot | 36 test | Mp Biomedicals Asia Pacific Pte. Ltd. | Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot |
| Multichem ID-HIV p24Techno-Path Manufacturing LimitedMultiple-type clinical chemistry analyte profile IVD, control | 09915494190 | Techno-Path Manufacturing Limited | Multiple-type clinical chemistry analyte profile IVD, control |
| OraQuick Advance HIV 1/2 Kit ControlsOrasure Technologies, Inc.HIV1/HIV2 antibody IVD, control | 1001-0077 | Orasure Technologies, Inc. | HIV1/HIV2 antibody IVD, control |
| OraQuick Advance Rapid HIV 1/2 Antibody TestOrasure Technologies, Inc.HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test | 3001-1197 | Orasure Technologies, Inc. | HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test |
| Procleix HIV-1/HCV/HBV Quality ControlGrifols Diagnostic Solutions Inc.HIV1 nucleic acid IVD, control | HIV-1 Positive Control | Grifols Diagnostic Solutions Inc. | HIV1 nucleic acid IVD, control |
| Procleix HIV-1/HCV/HBV Quality ControlGrifols Diagnostic Solutions Inc.Hepatitis B virus nucleic acid IVD, control | HBV Positive Control | Grifols Diagnostic Solutions Inc. | Hepatitis B virus nucleic acid IVD, control |
| Procleix WNV/Babesia Quality ControlGrifols Diagnostic Solutions Inc.PCR/NAT negative control IVD | WNV/Babesia Negative Control | Grifols Diagnostic Solutions Inc. | PCR/NAT negative control IVD |
| Procleix WNV/Babesia Quality ControlGrifols Diagnostic Solutions Inc.Multiple Babesia species nucleic acid IVD, control | Babesia Positive Control | Grifols Diagnostic Solutions Inc. | Multiple Babesia species nucleic acid IVD, control |
| Procleix WNV/Babesia Quality ControlGrifols Diagnostic Solutions Inc.West Nile virus nucleic acid IVD, control | WNV Positive Control | Grifols Diagnostic Solutions Inc. | West Nile virus nucleic acid IVD, control |
| Sentosa SQ HIV-1 Positive Control Kit (8)Vela Operations Singapore Pte. Ltd.HIV1 genotyping IVD, kit, nucleic acid technique (NAT) | 300800 | Vela Operations Singapore Pte. Ltd. | HIV1 genotyping IVD, kit, nucleic acid technique (NAT) |