Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

FDA classification

FDA Class 2 ·Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

FDA classification

FDA Class 2 ·Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Inherited Nucleotide Repeat Disorder Dna Test

FDA classification

FDA Class 2 ·Inherited Nucleotide Repeat Disorder Dna Test

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·SAHARA CLINICAL BONE SONOMETER

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Aquaporin-4 Autoantibody

FDA classification

FDA Class 2 ·Aquaporin-4 Autoantibody

Adamts13 Activity Test System

FDA classification

FDA Class 2 ·Adamts13 Activity Test System

Anti-Factor Xa Activity Test System, Apixaban

FDA classification

FDA Class 2 ·Anti-Factor Xa Activity Test System, Apixaban

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

Acute Kidney Injury Test System

FDA classification

FDA Class 2 ·Acute Kidney Injury Test System

Zika Virus Serological Reagents

FDA classification

FDA Class 2 ·Zika Virus Serological Reagents

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER

Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

Dengue Serological Reagents

FDA classification

FDA Class 2 ·Dengue Serological Reagents

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

FDA classification

FDA Class 2 ·Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

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

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV QUANT DX ASSAY