BladeFlask UNIVERSAL

FDA registration

QLICKSMART PTY., LTD.·1 product·🇦🇺 Australia

SnapIT

FDA registration

QLICKSMART PTY., LTD.·1 product·🇦🇺 Australia

Qlicksmart BladeCARTRIDGE

FDA registration

QLICKSMART PTY., LTD.·1 product·🇦🇺 Australia

Qlicksmart Needle Counter

FDA registration

QLICKSMART PTY., LTD.·1 product·🇦🇺 Australia

Qlicksmart Medication Labeling Device

FDA registration

QLICKSMART PTY., LTD.·1 product·🇦🇺 Australia

Qlicksmart Scalpel Blade Remover

FDA registration

QLICKSMART PTY., LTD.·1 product·🇦🇺 Australia

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Guangzhou HEAS BioTech Co., Ltd.

Manufacturer

🇨🇳 China

MetaOptima Technology Inc.

Manufacturer

🇨🇦 Canada·1 Importer

Xiamen Wiz Biotech Co., Ltd.

Manufacturer

🇨🇳 China·4 Basic UDI-DIs·4 Devices·1 Importer

Pall International SARL

Manufacturer

🇨🇭 Switzerland·1 Importer

bioLytical Laboratories Inc.

Manufacturer

🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S