Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

FDA classification

FDA Class 2 ·Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

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

FDA Pre-Market Approval

FDA Class 2 ·BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

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

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

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA 3.0 ASSAY (BDNA)

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

FDA classification

FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II TEST SYSTEM

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·OMNISENSE 7000S ULTRASOUND BONE SONOMETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV

Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids

FDA classification

FDA Class 2 ·Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids

Plasmodium Spp. Detection Reagents

FDA classification

FDA Class 2 ·Plasmodium Spp. Detection Reagents

Immunoassay, Anti-Seizure Drug

FDA classification

FDA Class 2 ·Immunoassay, Anti-Seizure Drug

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS TAQMAN HCV TEST VERSION 2.0

Hemoglobin A1c Test System

FDA classification

FDA Class 2 ·Hemoglobin A1c Test System

Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

FDA classification

FDA Class 2 ·Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230