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| Product | Model | Company | Device type |
|---|---|---|---|
| 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 |
| 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 | 661230 | Polymedco Cancer Diagnostic Products LLC | Bladder tumour associated antigen IVD, kit, rapid ICT, clinical |
| Cand-TecRamco Laboratories, Inc.Multiple candida species antigen IVD, kit, rapid agglutination, clinical | CO3/5 | Ramco Laboratories, Inc. | Multiple candida species antigen IVD, kit, rapid agglutination, clinical |
| Cand-TecRamco Laboratories, Inc.Multiple candida species antigen IVD, kit, rapid agglutination, clinical | CO3/1 | Ramco Laboratories, Inc. | Multiple candida species antigen IVD, kit, rapid agglutination, clinical |
| Cand-TecRamco Laboratories, Inc.Multiple candida species antigen IVD, kit, rapid agglutination, clinical | CO3/7 | Ramco Laboratories, Inc. | Multiple candida species antigen IVD, kit, rapid agglutination, 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 |
| FebriDx® Bacterial / Non-Bacterial AssayLumos Diagnostics, Inc.Multiple cell-mediated host immune response marker IVD, kit, rapid ICT, clinical | CP0517 | Lumos Diagnostics, Inc. | Multiple cell-mediated host immune response marker 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 |
| LEUKO EZ VUETechlab, Inc.Lactoferrin IVD, kit, rapid ICT, clinical | T30355 | Techlab, Inc. | Lactoferrin 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 |
| McKessonMckesson Medical-Surgical Inc.Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical | 18-001M | Mckesson Medical-Surgical Inc. | Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical |
| OraQuick Ebola Rapid Antigen TestOrasure Technologies, Inc.Ebola virus antigen IVD, kit, rapid ICT, clinical | 3001-2940 | Orasure Technologies, Inc. | Ebola virus 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 |
| 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 |
| 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 |
| RedLine Alert™ TestTetracore, Inc.Bacillus anthracis antigen IVD, kit, rapid ICT, clinical | — | Tetracore, Inc. | Bacillus anthracis antigen IVD, kit, rapid ICT, clinical |
| Sure-Vue Rota TestSA Scientific, Ltd.Rotavirus antigen IVD, kit, rapid ICT, clinical | 069005 | SA Scientific, Ltd. | Rotavirus antigen IVD, kit, rapid ICT, clinical |
| Synovasure® Alpha DefensinCd Diagnostics, Inc.Alpha defensin IVD, kit, rapid ICT, clinical | 00-8888-125-01 | Cd Diagnostics, Inc. | Alpha defensin IVD, kit, rapid ICT, clinical |
| Synovasure® Alpha DefensinCd Diagnostics, Inc.Alpha defensin IVD, kit, rapid ICT, clinical | 00-8888-125-10 | Cd Diagnostics, Inc. | Alpha defensin IVD, kit, rapid ICT, clinical |