General Chemistry Medical Devices Page: 123

BIOMEDIX, INC., Q STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM
Glucose monitoring devices (prescription use only) | 		MODERATE
Biomerica EZ Detect Stool Blood Test
Fecal occult blood | 		CLIA WAIVED
Biomerica RIA Test Kit
Creatine kinase BB fraction (CKBB) | Dehydroepiandrosterone sulfate (DHEA-SO4) | Estradiol | Estriol, unconjugated | Histamine | Myoglobin | Progesterone | Prostatic acid phosphatase (PAP) | Thyroid stimulating hormone (TSH) (neonatal) | 		View Complexity
Biomerieux Mini-Vidas
B-type natriuretic peptide (BNP) | Cancer antigen 15-3 (CA 15-3) | Prostatic specific antigen (PSA) | Testosterone | Thyroxine, free (FT4) | Troponin-I (cardiac) | Troponin-I (cardiac) | 		View Complexity
bioMerieux VIDAS
Alpha-fetoprotein – tumor marker | B-type natriuretic peptide (BNP) | Cancer antigen 15-3 (CA 15-3) | Carcinoembryonic antigen (CEA) | D-dimer | Prostatic specific antigen (PSA), free | Rubella antibodies | Testosterone | Thyroxine, free (FT4) | Troponin-I (cardiac) | Troponin-I (cardiac) | 		View Complexity
BIOMERIEUX VITEK VIDAS
Chlamydia | Clostridium difficile | Cortisol | Cortisol, urine (extraction procedure) | Creatine kinase MB fraction (CKMB) | Cytomegalovirus antibodies | D-dimer | Digoxin | Estradiol | Ferritin | Follicle stimulating hormone (FSH) | hCG, beta, serum, quantitative | Helicobacter pylori | Immunoglobulins IgE | Luteinizing hormone (LH) | Lyme disease antibodies (Borrelia burgdorferi Abs) | Mumps antibodies | Progesterone | Prolactin | Prostatic specific antigen (PSA) | Prostatic specific antigen (PSA) | Respiratory syncytial virus | Rotavirus | Rubella antibodies | Rubeola antibodies (measles) | T uptake (TU) | Theophylline | Thyroid stimulating hormone (TSH) | Thyroxine (T4) | Thyroxine, free (FT4) | Toxoplasma gondii antibodies | Toxoplasma gondii antibodies | Triiodothyronine (T3) | Varicella-zoster virus antibodies | 		View Complexity
BIOMIRA Diagnostics TRUQUANT BR RIA
Cancer antigen 27.29 (CA 27.29) | 		HIGH
Bionime Corporation GE Blood Glucose Monitoring System 180
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation GE Blood Glucose Monitoring System 182
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation GE100 Blood Glucose Monitoring System
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation iGlucose Blood Glucose Monitoring System
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation Rightest Blood Glucose Monitoring System
Glucose monitoring devices (FDA cleared/home use) | Glucose monitoring devices (FDA cleared/home use) | 		View Complexity
Bionime Corporation Rightest Blood Glucose Monitoring System GM280
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation Rightest Blood Glucose Monitoring System GM280B
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation Rightest Blood Glucose Monitoring System GM720
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM100
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM110
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation Rightest Professional Blood Glucose Monitoring System GM720
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation, GE Blood Glucose Monitoring System 333
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation, Rightest GM250 Blood Glucose Monitoring System
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Corporation, Rightest GM260 Blood Glucose Monitoring System
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime GE 300 Talking Blood Glucose Monitoring system
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime GE200 Blood Glucose Monitoring System
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime GE300 Talking Blood Glucose Monitoring System
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Rightest Blood Glucose Monitoring System, GM700
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED
Bionime Rightest Blood Glucose Monitoring System, Model GM650
Glucose monitoring devices (FDA cleared/home use) | Glucose monitoring devices (FDA cleared/home use) | 		View Complexity
Bionime USA Corporation Rightest Blood Glucose Monitoring System, Model GM550
Glucose monitoring devices (FDA cleared/home use) | 		CLIA WAIVED

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