Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

FDA classification

FDA Class 2 ·Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

FDA classification

FDA Class 2 ·Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

Zinc Transporter 8 Auto-Antibody

FDA classification

FDA Class 2 ·Zinc Transporter 8 Auto-Antibody

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

FDA classification

FDA Class 2 ·Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV ON CENTAUR CP

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

FDA Pre-Market Approval

FDA Class 2 ·TOTAL PSA MICROTITER ELISA

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS

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

FDA Pre-Market Approval

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

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

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

FDA classification

FDA Class 2 ·Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Serpina1 Variant Detection System

FDA classification

FDA Class 2 ·Serpina1 Variant Detection System

21-Hydroxylase Antibody (21-Ohab)

FDA classification

FDA Class 2 ·21-Hydroxylase Antibody (21-Ohab)

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

Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

FDA classification

FDA Class 2 ·Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

FDA Class 2 ·Device To Detect Microbial Colonization Directly From Clinical Specimens.