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Aalto Scientific, Ltd.

United States·US-MF-000043518

Last updated June 8, 2026

Information

Country
United States
Address
230 Technology Parkway, Eatonton, United States
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Robert Burda
EUDAMED SRN
US-MF-000043518
FDA FEI Number
—
DUNS Number
—

Catalogue (201)

Page 2 of 5
DeviceModel / ReferenceRegistriesClassStatus
Audit MicroControls Linearity FLQ General Chemistry Panel 2 for Roche Systems K918M-5
FDA UDI
N/AActive
Audit MicroControls Control FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH K089M-8
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ Special Diabetes for Abbott Systems K956M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry Panel 3 for Abbott Systems K942M-5
FDA UDI
N/AActive
Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1) K852M-20
FDA UDI
N/AActive
Audit MicroControls Linearity FD D-Dimer bioMerieux VIDAS and miniVIDAS K845M-5
FDA UDI
N/AActive
Audit MicroControls Control FD HE4, HER2 Tumor Markers K079M-6
FDA UDI
N/AActive
Audit MicroControls Linearity LQ Homocysteine Siemens Centaur K801M-5
FDA UDI
N/AActive
Audit MicroControls Linearity LQ Ammonia/Alcohol for Ortho Vitros K830M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry Panel 4 for Abbott Systems K943M-5
FDA UDI
N/AActive
Audit MicroControls Control DROPLQ Urine Dipstick K065M-4
FDA UDI
N/AActive
Audit MicroControls Linearity FD Cardiac Markers for Ortho Vitros K906M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD BNP (Extended) K737M-5
FDA UDI
N/AActive
Audit MicroControls Linearity LQ RF/CRP K720M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD iPTH for Abbott Systems K957M-5
FDA UDI
N/AActive
Audit MicroControls Linearity DROP LQ Blood Glucose K736M-5
FDA UDI
N/AActive
Audit MicroControls Control LQ Vitamin D K075M-6
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ TDM for Beckman AU K827M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD HbA1c K703M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Immunoassay for Abbott Systems K833M-5
FDA UDI
N/AActive
Audit MicroControls Linearity DROP LQ Fructosamine for Roche Systems K930M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD D-Dimer PATHFAST Immunoanalyzer K883M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry Panel 2 for Alfa Wassermann K865M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ Anti-Mullerian Hormone for Roche Systems K896M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Anemia Siemens Atellica K809M-5
FDA UDI
N/AActive
Audit MicroControls Linearity LQ Beta-Hydroxybutyric Acid K728M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Cardiac Siemens Stratus K891M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry Panel 3 for Alfa Wassermann K866M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ Vitamin D for Ortho Vitros K910M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Cardiac Markers K710M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Procalcitonin for Roche Systems K894M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ ISE + Trigs for Siemens Dimension K960M-5
FDA UDI
N/AActive
Audit MicroControls Control LQ COVID-19 Antibodies K077M-6
FDA UDI
N/AActive
Audit MicroControls Control FD HbA1c K061M-6
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry K701M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry Panel 3 for Ortho Vitros K902M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ General Chemistry Panel 3 for Roche Systems K919M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Cardiac RAMP K887M-5
FDA UDI
N/AActive
Linearity FD Procalcitonin for Siemens Atellica K814M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry Panel 4 for Ortho Vitros K903M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Special Diabetes for Ortho Vitros K909M-5
FDA UDI
N/AActive
Audit MicroControls Control LQ RF/CRP K073M-6
FDA UDI
N/AActive
Audit MicroControls Linearity FD Immunoassay K714M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, U K846M-10
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ Special Diabetes for Roche Systems K922M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD BNP Siemens Stratus K892M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD HE4, HER2 Tumor Markers K738M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry Panel 4 for Alfa Wassermann K867M-10
FDA UDI
N/AActive
Audit MicroControls Linearity FD D-Dimer Siemens Stratus K893M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD TDM K707M-5
FDA UDI
N/AActive

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