Hematology Medical Devices Page: 6
| Advia 2120/2120i Red blood cell count (erythrocyte count) (RBC) | White blood cells, enumerated | | View Complexity |
| Affinity Biologicals Inc VisuLize Factor IX Antigen Kit Factor IX antigen | | HIGH |
| AGEN BIOMEDICAL DIMERTEST LATEX ASSAY D-dimer | D-dimer | | View Complexity |
| AGEN BIOMEDICAL SIMPLIRED D-DIMER ASSAY D-dimer | | MODERATE |
| AGEN Dimertest Gold EIA D-dimer | | HIGH |
| Agena Bioscience IMPACT Dx System Factor II (prothrombin) G20210A | Factor V leiden | | View Complexity |
| AggreGuide A-100 instrument, and AggreGuide A-100 AA assay Platelet function | | MODERATE |
| AI AnalysInstrument AB ESR-100 Erythrocyte sedimentation rate (non-waived proced) | | MODERATE |
| AI AnalysInstrument AB ESR-8 Erythrocyte sedimentation rate (non-waived proced) | | MODERATE |
| AimStrip Hb Hemoglobin (Hb) Testing System Hemoglobin | | CLIA WAIVED |
| AirScan ESR STAT PLUS Erythrocyte sedimentation rate (non-waived proced) | | MODERATE |
| AKERS LABORATORIES HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY Platelet factor IV | | HIGH |
| Alere Clearview Simplify D-dimer D-dimer | | MODERATE |
| Alere HemoPoint H2 Hemoglobin Measurement System Hemoglobin | | CLIA WAIVED |
| Alere HemoPoint H2 Hemoglobin System Hemoglobin | | CLIA WAIVED |
| Alere HemoPoint H2 System Hemoglobin | | CLIA WAIVED |
| Alere INRatio�2 PT/INR Home Monitoring System Prothrombin time (PT) | | CLIA WAIVED |
| Alere INRatio�2 PT/INR Monitoring System (Professional Use) Prothrombin time (PT) | | CLIA WAIVED |
| Alere Triage D-Dimer Test D-dimer | | MODERATE |
| Alere Triage MeterPro B-type natriuretic peptide (BNP) | Creatine kinase MB fraction (CKMB) | D-dimer | Myoglobin | Troponin-I (cardiac) | | View Complexity |
| Alere, INRatio 2 PT/INR Monitoring System Prothrombin time (PT) | | CLIA WAIVED |
| Alfa Wassermann ACE Clinical Chemistry Analyzer Fibrinogen | | MODERATE |
| Alfa Wassermann, Inc. ACE Alera Clinical Chemistry System Fibrinogen | | MODERATE |
| All Body Fluid Elements Microscopic ID Procedures Body fluid microscopic elements | | HIGH |
| All Fecal Smears for Leukocytes Leukocytes, fecal | | MODERATE |
| All Manual Cerebrospinal Fluid Cell Count Procedures Cerebrospinal fluid microscopic elements | | HIGH |
| All Manual Eosinophil Count Procedures Eosinophils | | HIGH |
| All Manual Platelet Count Test Systems and Procedures Platelet count | | HIGH |
| All Manual Red Blood Cell Count Procedures Red blood cell count (erythrocyte count) (RBC) | | HIGH |
| All Manual Reticulocyte Count Test Systems and Procedures Reticulocyte count | | MODERATE |
| All Manual Semen Analyses Semen | | MODERATE |
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