AMEBIASIS MICROASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

E. HISTOLYTICA QUIK CHEK

FDA 510(k)

FDA Class 2 ·Microbiology

ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC)

FDA 510(k)

FDA Class 2 ·Microbiology

HILLCREST AMEBIASIS IHA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

GIARDIA STOOL ANTIGEN TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)

FDA 510(k)

FDA Class 2 ·Microbiology

AMEBIASIS ELISA TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH LITHOTRIPTER

System, Test, Human Chorionic Gonadotropin

FDA classification

FDA Class 2 ·System, Test, Human Chorionic Gonadotropin

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER

Human Lyophilized Dura Mater

FDA classification

FDA Class 2 ·Human Lyophilized Dura Mater

Immunoglobulin G (Igg) Infusion System

FDA classification

FDA Class 2 ·Immunoglobulin G (Igg) Infusion System

Infusion Pump, Drug Specific, Pharmacy-Filled

FDA classification

FDA Class 2 ·Infusion Pump, Drug Specific, Pharmacy-Filled

Digital Pathology Display

FDA classification

FDA Class 2 ·Digital Pathology Display

System, Suction, Lipoplasty

FDA classification

FDA Class 2 ·System, Suction, Lipoplasty

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II TEST SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READYPACKS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY

Test, Methadone, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Methadone, Employment And Insurance Testing, Exempt

Whole Exome Sequencing Constituent Device

FDA classification

FDA Class 2 ·Whole Exome Sequencing Constituent Device