DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

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 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure 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 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure 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 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure 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 and COBAS TaqMan HCV TEst, v2.0 for use on the High Pure System

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

FDA classification

FDA Class 2 ·Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

Device For Sleep Apnea Testing Based On Mandibular Movement

FDA classification

FDA Class 2 ·Device For Sleep Apnea Testing Based On Mandibular Movement

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

Light Based Over The Counter Wrinkle Reduction

FDA classification

FDA Class 2 ·Light Based Over The Counter Wrinkle Reduction

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification

FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Aid, Cardiopulmonary Resuscitation

FDA classification

FDA Class 2 ·Aid, Cardiopulmonary Resuscitation

Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

FDA classification

FDA Class 2 ·Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

Anti Fog Solution And Accessories, Endoscopy

FDA classification

FDA Class 2 ·Anti Fog Solution And Accessories, Endoscopy

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

FDA classification

FDA Class 2 ·Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

FDA classification

FDA Class 2 ·Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Posterior Cervical Screw Placement Guide

FDA classification

FDA Class 2 ·Posterior Cervical Screw Placement Guide

External Cleaning Solution

FDA classification

FDA Class 2 ·External Cleaning Solution

Multivariate Vital Signs Index

FDA classification

FDA Class 2 ·Multivariate Vital Signs Index