11-Dehydro Thromboxane B2 Kit, Urinary

FDA classification

FDA Class 2 ·11-Dehydro Thromboxane B2 Kit, Urinary

Protamine Sulphate

FDA classification

FDA Class 2 ·Protamine Sulphate

Hemoglobin F Quantitation

FDA classification

FDA Class 2 ·Hemoglobin F Quantitation

Aggregometer, Platelet, Thrombokinetogram

FDA classification

FDA Class 2 ·Aggregometer, Platelet, Thrombokinetogram

Instrument, Automated Platelet Counting

FDA classification

FDA Class 2 ·Instrument, Automated Platelet Counting

Cryogenic Cord Blood Storage Container

FDA classification

FDA Class 2 ·Cryogenic Cord Blood Storage Container

Progenitor Cell Enumeration

FDA classification

FDA Class 2 ·Progenitor Cell Enumeration

Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase

FDA classification

FDA Class 2 ·Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase

Activated Partial Thromboplastin

FDA classification

FDA Class 2 ·Activated Partial Thromboplastin

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification

FDA Class 2 ·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

Candida Species Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Candida Species Nucleic Acid Detection System

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0

Tracheal Prosthesis With Cover Material Derived From Human Sources

FDA classification

FDA Class 2 ·Tracheal Prosthesis With Cover Material Derived From Human Sources

Closed Loop Auto Titration Device For Oral Appliances

FDA classification

FDA Class 2 ·Closed Loop Auto Titration Device For Oral Appliances

Spinal Muscular Atrophy Newborn Screening Test System

FDA classification

FDA Class 2 ·Spinal Muscular Atrophy Newborn Screening Test System

Artificial Chordae Tendineae Surgical Replacement System

FDA classification

FDA Class 2 ·Artificial Chordae Tendineae Surgical Replacement System

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

FDA classification

FDA Class 2 ·Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

FDA classification

FDA Class 2 ·Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

Bone Sonometer

FDA classification

FDA Class 2 ·Bone Sonometer

Novel Influenza A Virus, A/H5 Ns1 Protein

FDA classification

FDA Class 2 ·Novel Influenza A Virus, A/H5 Ns1 Protein