| Active Anthrax Detect Plus Rapid TestInbios International, IncBacillus anthracis antigen IVD, kit, rapid ICT, clinical | AAP-1 | Inbios International, Inc | Bacillus anthracis antigen IVD, kit, rapid ICT, clinical |
| Adenovirus Antigen Detection Kit (Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Adenovirus antigen IVD, kit, rapid ICT, clinical | 20 tests/kit | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | Adenovirus antigen IVD, kit, rapid ICT, clinical |
| BinaxNOW Streptococcus pneumoniae Antigen CardAlere Scarborough, Inc.Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical | 710-000 | Alere Scarborough, Inc. | Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical |
| BTA statPolymedco Cancer Diagnostic Products LLCBladder tumour associated antigen IVD, kit, rapid ICT, clinical | 661010 | Polymedco Cancer Diagnostic Products LLC | Bladder tumour associated antigen IVD, kit, rapid ICT, clinical |
| BTA statPolymedco Cancer Diagnostic Products LLCBladder tumour associated antigen IVD, kit, rapid ICT, clinical | 661210 | Polymedco Cancer Diagnostic Products LLC | Bladder tumour associated antigen IVD, kit, rapid ICT, clinical |
| BTA statPolymedco Cancer Diagnostic Products LLCBladder tumour associated antigen IVD, kit, rapid ICT, clinical | 661230 | Polymedco Cancer Diagnostic Products LLC | Bladder tumour associated antigen IVD, kit, rapid ICT, clinical |
| CARDINAL HEALTHCardinal Health 200, LLCMultiple faecal parasite antigen IVD, kit, rapid ICT, clinical | CH6830 | Cardinal Health 200, LLC | Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical |
| Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical | 10 tests/kit | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical |
| Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical | 50 tests/kit | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical |
| IconBeckman Coulter, Inc.Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical | 395100 | Beckman Coulter, Inc. | Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical |
| LifeSign® MI Myo/TnI cardPrinceton Biomeditech CorporationMyoglobin IVD, kit, rapid ICT, clinical | LSC-210-20-00 | Princeton Biomeditech Corporation | Myoglobin IVD, kit, rapid ICT, clinical |
| OSOM RSV TestSekisui Diagnostics, LLCRespiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical | 1091 | Sekisui Diagnostics, LLC | Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical |
| OSOM Trich V. 25 Test KitSekisui Diagnostics, LLCTrichomonas vaginalis antigen IVD, kit, rapid ICT, clinical | 181 | Sekisui Diagnostics, LLC | Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical |
| PEPFASTRD Biomed (Changsha) LimitedPepsin IVD, kit, rapid ICT, clinical | PEPF10 | RD Biomed (Changsha) Limited | Pepsin IVD, kit, rapid ICT, clinical |
| PEPFASTRD Biomed (Changsha) LimitedPepsin IVD, kit, rapid ICT, clinical | PEPF50 | RD Biomed (Changsha) Limited | Pepsin IVD, kit, rapid ICT, clinical |
| Platelet PGDprime Processing TubesVerax Biomedical IncorporatedLipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical | P01463 | Verax Biomedical Incorporated | Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical |
| Platelet PGDprime Reagent 1AVerax Biomedical IncorporatedLipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical | P01111 | Verax Biomedical Incorporated | Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical |
| Platelet PGDprime Reagent 2Verax Biomedical IncorporatedLipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical | P01214 | Verax Biomedical Incorporated | Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical |
| Platelet PGDprime Transfer PipettesVerax Biomedical IncorporatedLipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical | P01229 | Verax Biomedical Incorporated | Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical |
| Poly statPolymedco, Inc.Helicobacter pylori antigen IVD, kit, rapid ICT, clinical | HP20 | Polymedco, Inc. | Helicobacter pylori antigen IVD, kit, rapid ICT, clinical |
| QuickVueQuidel CorporationMultiple Chlamydia species antigen IVD, kit, rapid ICT, clinical | 0B006 | Quidel Corporation | Multiple Chlamydia species antigen IVD, kit, rapid ICT, clinical |
| Rapid ResponseBTNX IncRotavirus antigen IVD, kit, rapid ICT, clinical | ROT-9C20 | BTNX Inc | Rotavirus antigen IVD, kit, rapid ICT, clinical |
| Rapid ResponseBTNX IncAdenovirus antigen IVD, kit, rapid ICT, clinical | ADE-9C20 | BTNX Inc | Adenovirus antigen IVD, kit, rapid ICT, clinical |
| RedLine Alert™ TestTetracore, Inc.Bacillus anthracis antigen IVD, kit, rapid ICT, clinical | — | Tetracore, Inc. | Bacillus anthracis antigen IVD, kit, rapid ICT, clinical |
| Status BTA CardPrinceton Biomeditech CorporationBladder tumour associated antigen IVD, kit, rapid ICT, clinical | BSP-307-10-00 | Princeton Biomeditech Corporation | Bladder tumour associated antigen IVD, kit, rapid ICT, clinical |