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VIRGO AMA ELISA KIT

FDA 510(k)
FDA Class 2 ·Immunology

TEST KIT, IIF-AMA

FDA 510(k)
FDA Class 2 ·Immunology

Trinity Biotech

FDA UDI
MARDX DIAGNOSTICS, INC.·05391516747776·FTA-ABS Reactive Control, 0.5 mL

PK7400 TP HA CONTROLS

FDA UDI
NEWMARKET BIOMEDICAL LIMITED·05060515140047·PK7400 TP HA CONTROLS is intended for use with ...

Trinity Biotech

FDA UDI
MARDX DIAGNOSTICS, INC.·05391516747769·FTA-ABS Nonspecific Control, 0.5 mL

Nexalin

FDA UDI
NEXALIN TECHNOLOGY·B788KS02000·

Nexalin

FDA UDI
NEXALIN TECHNOLOGY·B788KS02001·Patient cable for transcranial electrical stimu...

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Preveleak Surgical Sealant

CMA CEREBRAL TISSUE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

CMA CEREBRAL TISSUE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

Olive Plus

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PRESTYL JET INJECTOR

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

VENTANA FOLR1 Stain Intensity Reference Slide

FDA UDI
Ventana Medical Systems, Inc.·07613336188019·

VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

FDA UDI
Ventana Medical Systems, Inc.·07613336103241·

Novocastra™

FDA UDI
LEICA BIOSYSTEMS NEWCASTLE LTD·05055331309174·NCL-L-FRalpha is intended for the qualitative i...

Novocastra

FDA UDI
LEICA BIOSYSTEMS NEWCASTLE LTD·05055331333759·NCL-L-FRalpha-U is intended for the qualitative...

Folate Receptor alpha IHC Assay Kit

FDA UDI
BIOCARE MEDICAL LLC·00847627005182·