Power Processor

FDA registration

IDS CO, LTD·5 products·🇯🇵 Japan

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740156275·Quantia Ferritin

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740156329·Quantia Ferritin Calibrators

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740057718·Quantia Ferritin

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740030094·Quantia Ferritin Calibrators

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT(R) 3 FOR EXT WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR

ABX PENTRA TOTAL PROTEIN CP

FDA registration

HORIBA ABX SAS·6 products·🇫🇷 France

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

hybcell Bacteria DNA xB

Basic UDI-DI

EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

hybcell Fungi DNA xB

Basic UDI-DI

EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

hybcell Pathogens DNA xB

Basic UDI-DI

EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

PCR-Box Bacteria

Basic UDI-DI

EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device