MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Device

EU MDR · Eu Md Class 2a ·HCI Solutions AG·Not intended for eu market

DENTAL TREATMENT UNITS

Device

EU MDR · Eu Md Class 1 ·DCI International, LLC·On the market·12 countries

Xpert HemosIL FII & FV

FDA registration

Cepheid·3 products·🇺🇸 United States

Xpert FII & FV

FDA registration

CEPHEID·3 products·🇺🇸 United States

Xpert FII & FV

FDA registration

Cepheid·3 products·🇺🇸 United States

Xpert HemosIL FII & FV

FDA registration

CEPHEID·3 products·🇺🇸 United States

INFINITI FACTOR II-V Assay

FDA registration

AUTOGENOMICS, INCORPORATED·3 products·🇺🇸 United States

Fast 96-Well Spectral Calibration Plate with VIC™ Dye

FDA UDI

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·10190302000383·

Rnase P Fast 384-Well Instrument Verification Plate

FDA UDI

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·10190302000321·

384-Well Normalization Plates with FAM/ROX and VIC/ROX Dyes

FDA UDI

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·10190302000406·

Helix Elite™ Molecular Standards: Inactivated Standard

FDA UDI

MICROBIOLOGICS INC.·10845357043624·Helix Elite™ Molecular Standards Negative Cellu...

Ion Torrent™ Dx No Template Control Kit

FDA UDI

LIFE TECHNOLOGIES CORPORATION·10190302006156·

384-Well Spectral Calibration Plate with Cy®5 Dye

FDA UDI

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·10190302018869·

Ion Torrent

FDA UDI

LIFE TECHNOLOGIES CORPORATION·10190302000888·

RNase P 96-Well Instrument Verification Plate

FDA UDI

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·10190302000369·

cobas® NHP Negative Control Kit

FDA UDI

Roche Diagnostics GmbH·00875197005127·

Inocu Swabs

FDA UDI

MICROBIOLOGICS INC.·10634853001272·Group B Strep Negative

Acuitas

FDA UDI

Opgen, Inc.·00812125010044·Assay Control is used to monitor extraction eff...

ACCURUN®

FDA UDI

Lgc Clinical Diagnostics, Inc.·00816784020710·ACCURUN 803 NUCLEIC ACID HIV, HCV, HBV 10 x 1.2 mL

Procleix WNV/Babesia Quality Control

FDA UDI

GRIFOLS DIAGNOSTIC SOLUTIONS INC.·00850032683043·Procleix WNV/Babesia Quality Control, a set of ...