Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas® CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQ/MAN CYTOMEGALOVIRUS TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Aptima CMV Quant Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Cobas CMV

VYSIS D7S486/CEP 7 FISH PROBE KIT

FDA 510(k)

FDA Class 2 ·Hematology

Xpert Carba-R

FDA 510(k)

FDA Class 2 ·Microbiology

Invitae Common Hereditary Cancers Panel

FDA 510(k)

FDA Class 2 ·Pathology

BD MAX Check-Points CPO

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Carba-R

FDA 510(k)

FDA Class 2 ·Microbiology

MAXONE IV FLUID/BLOOD WARMER, MODEL 102

FDA 510(k)

FDA Class 2 ·General Hospital

PARAMAX URINE/CSF CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

SECONDARY IV SET WITH PROTECTED NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

VITRECTOMY CUTTER AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ophthalmic

PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600

FDA 510(k)

FDA Class 2 ·Cardiovascular

PCI MODEL 2041-PC TELEMETRY MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

HYALURONIDASE SOLUTION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TASSI MK3 (TURNAIR)

FDA 510(k)

FDA Class 2 ·Physical Medicine

DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET

FDA 510(k)

FDA Class 2 ·Hematology