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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 3 of 5
DeviceModel / ReferenceRegistriesClassStatus
Audit MicroControls Control LQ hs-CRP K021M-6
FDA UDI
Class IActive
Audit MicroControls Linearity FLQ Fertility Siemens Atellica K818M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Lipids Beckman AU K826M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Procalcitonin for Abbott Systems K834M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ General Chemistry Panel 1 for Roche Systems K917M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ Vitamin D for Roche Systems K923M-5
FDA UDI
N/AActive
Audit MicroControls Linearity LQ Vitamin D K729M-5
FDA UDI
N/AActive
Audit MicroControls Cal Ver FLQ Drugs of Abuse for Beckman AU K821M-4
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ HbA1c K761M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry Panel 2 for Ortho Vitros K901M-5
FDA UDI
N/AActive
Audit MicroControls Control FLQ Vitamin D K082M-10
FDA UDI
N/AActive
Audit MicroControls Linearity LQ TIBC for Ortho Vitros K905M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry Beckman AU K824M-5
FDA UDI
N/AActive
Audit MicroControls Cal Ver FLQ Drugs of Abuse for Roche Systems K931M-4
FDA UDI
N/AActive
Audit MicroControls Linearity FD Procalcitonin bioMerieux VIDAS and miniVIDAS K841M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Bilirubin for Roche Systems K886M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry for Roche Systems K880M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Bilirubin Supplement K701M-SUPP
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ Troponin T for Roche Systems K932M-5
FDA UDI
N/AActive
Audit MicroControls Cal Ver LQ T-Uptake Tosoh AIA K851M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ TDM for Abbott Systems K950M-5
FDA UDI
N/AActive
Audit MicroControls Control LQ HbA1c K067M-8
FDA UDI
N/AActive
Audit MicroControls Linearity FD Thyroid for Abbott Systems K832M-5
FDA UDI
N/AActive
Audit MicroControls Control DROPLQ Urine Dipstick K064M-10
FDA UDI
N/AActive
Audit MicroControls Linearity LQ Ammonia/Ethanol for Abbott Systems K899M-5
FDA UDI
N/AActive
Audit MicroControls Linearity LQ Anti-SARS-CoV-2 S for Roche Systems K921M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ Vitamin D K764M-5
FDA UDI
N/AActive
Audit MicroControls Control FD for bioMérieux VIDAS® NEPHROCLEAR CCL14 K090M-8
FDA UDI
N/AActive
Audit MicroControls Linearity FD BNP Siemens Atellica K803M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Urine Chemistry Panel 1 K897M-5
FDA UDI
N/AActive
Audit MicroControls MethodVal FD Procalcitonin bioMerieux VIDAS and miniVIDAS K842M-25
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry Beckman AU K820M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Bilirubin Beckman AU K825M-5
FDA UDI
N/AActive
Audit MicroControls Control LQ Spinal Fluid K060M-6
FDA UDI
N/AActive
Audit MicroControls Linearity FD Tumor Markers Siemens Atellica K805M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD D-Dimer K717M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Lipids K709M-5
FDA UDI
N/AActive
Audit MicroControls Control FD Tumor Markers K070M-6
FDA UDI
N/AActive
Audit MicroControls Control LQ COVID-19 IgG + IgM Antibodies K087M-6
FDA UDI
N/AActive
Audit MicroControls Linearity FD iPTH for Ortho Vitros K904M-5
FDA UDI
N/AActive
Audit MicroControls Control FD Urine Chemistry K0661-10
FDA UDI
N/AActive
Audit MicroControls Linearity FD iPTH for Roche Systems K934M-5
FDA UDI
N/AActive
Audit MicroControls Control FD Urine Chemistry K0662-10
FDA UDI
N/AActive
Audit MicroControls Control FD Assayed Chemistry, Level 1 K0311-10
FDA UDI
N/AActive
Audit MicroControls Control LQ Vitamin D for Roche Systems K080M-6
FDA UDI
N/AActive
Audit MicroControls Linearity LQ Ammonia/Ethanol for Roche Systems K881M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Tumor Markers K719M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ Fertility for Roche Systems K927M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Urine Chemistry Panel 2 K898M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ TDM for Roche Systems K933M-5
FDA UDI
N/AActive

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