DC-LIP, CATALOGUE NUMBER SE-020

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DC-LIQUICAL CATALOGUE #SE-030

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHLORIDE ASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DC-UIBC-CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMMONIA ASSAY CAT. NO. 200-02

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES

FDA 510(k)

FDA Class 1 ·Ophthalmic

X-AMYLASE ASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DC-3 FLUIDS PACK, DC-5 FLUIDS PACK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Genvinset® PAI-1/FXIII multiplex

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Blackhills Diagnostic Resources S.L.U.·3 devices

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

CYBOW R-60S

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DFI Co.,Ltd.·3 devices

CYBOW R-50S

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DFI Co.,Ltd.·6 devices

CYBOW R-600S

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DFI Co.,Ltd.·4 devices

CYBOW Reader 300

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DFI Co.,Ltd.·5 devices