10,000 results · 47ms · Sources: EU EUDAMED, US FDA

BIOLIS 30i

FDA registration
Tokyo Boeki Medisys Inc.·2 products·🇯🇵 Japan

Alinity c Processing Module (LN 03R6701)

FDA registration
ABBOTT LABORATORIES·2 products·🇺🇸 United States

Sekisui Diagnostics P.E.I. Inc.

FDA registration
Sekisui Diagnostics P.E.I. Inc.·2 products·🇨🇦 Canada

Atellica CH Glucose Oxidase (GluO)

FDA registration
RANDOX LABORATORIES LIMITED·2 products·🇬🇧 United Kingdom

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ACCESS AFP IMMUNOASSAY SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH PSA ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT

P2psa

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

CLC480 Chemistry Analyzer W/ISE

FDA UDI
CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302023169·CLC480 Chemistry Analyzer W/ISE

Vapotherm

FDA UDI
VAPOTHERM, INC.·00841737103547·Precision Flow Heliox UKIT, France

Vapotherm

FDA UDI
VAPOTHERM, INC.·00841737102809·Precision Flow Heliox UKIT, France

Mediflex Deluxe Laparoscopic Instruments

FDA UDI
FLEXBAR MACHINE CORPORATION·00842102102998·Delux 10mm Claw Forceps, 36cm, SA Jaw

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4

FDA 510(k)
FDA Class 2 ·Radiology

Analyzer

FDA registration
Diamond Diagnostics Inc.·3 products·🇭🇺 Hungary

Poly-Chem 90

FDA registration
FURUNO ELECTRIC CO., LTD.·3 products·🇯🇵 Japan

ABX PENTRA GLUCOSE HK CP

FDA registration
HORIBA ABX SAS·3 products·🇫🇷 France

GLUCOSE HK SL, Ref.GHSL-0250

FDA registration
VitalScientific·3 products·🇫🇷 France

Novum IQ

FDA UDI
BAXTER HEALTHCARE CORPORATION·05413765852428·The Novum IQ Syringe Pump is software controll...

PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry