Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS

Placental Alpha Microglobulin-1 Immunoassay

FDA Pre-Market Approval

FDA Class 3 ·PartoSure Test

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·Quantiferon TB Gold

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MIC TEST PANELS

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test

Dna-Probe, B And T Lymphocyte

FDA Pre-Market Approval

FDA Class 2 ·ONCOR B/T GENE REARRANGEMENT TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay/BD COR System

Enzyme Immunoassay, Cannabinoids

FDA Pre-Market Approval

FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL(TM) EV VASCULAR CLOSURE DEVICE/8 AND 6 FRENCH

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON TB GOLD IN-TUBE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VIP Vascular Closure Device

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System