General Immunology Medical Devices Page: 35
| Biometric Imaging IMAGN 2000 Lymphocytes, CD4 | Lymphocytes, CD8 | | View Complexity |
| Biometric Imaging Volumet 1000 Lymphocytes, CD4 | Lymphocytes, CD8 | | View Complexity |
| Bion ANA Test Kit Anti-nuclear antibodies (ANA) | | HIGH |
| Bion CMV-G Antibody Test System Cytomegalovirus antibodies | | HIGH |
| Bion Diagnostic Sciences BTA stat Test Bladder tumor associated antigen | | CLIA WAIVED |
| Bion EBV-G (VCA) Antibody Test System Epstein-Barr virus antibodies | | HIGH |
| Bion EBV-M (VCA) Antibody Test System Epstein-Barr virus antibodies | | HIGH |
| Bion HSV1-G or HSV2-G Test System Herpes simplex I and/or II antibodies | | HIGH |
| Bion Measles-G Antibody Test System Rubeola antibodies (measles) | | HIGH |
| Bion Measles-M Antibody Test System Rubeola antibodies (measles) | | HIGH |
| Bion Mumps-G Antibody Test System Mumps antibodies | | HIGH |
| Biopool Imulyse ACA Anti-cardiolipin antibodies | | HIGH |
| BIORAPID MONONUCLEOSIS Infectious mononucleosis antibodies (mono) | | MODERATE |
| BioStar Acceava Mono II Infectious mononucleosis antibodies (mono) | | MODERATE |
| BioStar Acceava Mono Test Infectious mononucleosis antibodies (mono) | | MODERATE |
| BioTek Solutions TechMate Leukocyte common antigen (LCA) | | HIGH |
| Bioview Ltd. Duet System (Version 3.5) Anaplastic lymphoma kinase gene | | HIGH |
| BioWhittaker 3M Allergen Specific IgE FAST-Plus Test Allergen specific IgE | | HIGH |
| BioWhittaker 3M Allergen Specific IgG4 FAST Test Allergen specific IgG | | HIGH |
| BioWhittaker 3M IgE FASTSCREEN Test Allergen specific IgE | | HIGH |
| BioWhittaker 3M IgG/IgM FASTLYME Test Lyme disease antibodies (Borrelia burgdorferi Abs) | | HIGH |
| BioWhittaker 3M Total IgE II FAST Test Immunoglobulins IgE | | HIGH |
| BioWhittaker CHLAMYDELISA II Chlamydia trachomatis antibodies | | HIGH |
| BioWhittaker CHLAMYDIA STAT Chlamydia trachomatis antibodies | | HIGH |
| BioWhittaker CMV CAP-M Cytomegalovirus antibodies | | HIGH |
| BioWhittaker CMV STAT Cytomegalovirus antibodies | | HIGH |
| BioWhittaker CMV STAT M Cytomegalovirus antibodies | | HIGH |
| BioWhittaker CYTOMEGELISA II Cytomegalovirus antibodies | | HIGH |
| BioWhittaker dsDNA STAT Anti-DNA antibodies | | HIGH |
| BioWhittaker EB VCA STAT Epstein-Barr virus antibodies | | HIGH |
| BioWhittaker EB VCA STAT M Epstein-Barr virus antibodies | | HIGH |
| BioWhittaker EBNA STAT Epstein-Barr virus antibodies | | HIGH |
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