FDA Registration Active 🇺🇸 United States

AALTO SCIENTIFIC LTD.

Reg #: 3011325031 · FEI: 3011325031 · Expires 2026
Products
7
Proprietary Names
118
Establishment Types
3
Classifications
7

Registration Details

Registration Name
AALTO SCIENTIFIC LTD.
Registration Number
3011325031
FEI Number
3011325031
Status
Active
Expiry Year
2026
Initial Importer
No
Address
230 Technology Pkwy
City
Eatonton
State
GA
ZIP
31024
Country
US

Owner / Operator

Firm Name
AALTO SCIENTIFIC LTD.
Operator Number
9000089
Address
230 Technology Parkway, --
City
Eatonton
State
GA
Postal Code
31024
Country
US
Correspondent
Robert - Burda

Products

Device Name Product Code
Plasma, Coagulation Control GGN
Kit, Serological, Positive Control MJX
Enzyme Controls (Assayed And Unassayed) JJT
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
Multi-Analyte Controls, All Kinds (Assayed) JJY
Controls For Blood-Gases, (Assayed And Unassayed) JJS
Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD

Proprietary Names

Linearity FD D-Dimer for bioMerieux VIDAS Linearity FD D-Dimer PATHFAST Immunoanalyzer Linearity FD D-Dimer Control FD D-Dimer Linearity FD D-Dimer for Stago Systems Control FD Procalcitonin Linearity FD Procalcitonin for bioMerieux VIDAS Control FD G6PD for Baebies FINDER Control FD for bioMerieux VIDAS® NEPHROCLEAR CCL14 Linearity FD NT-proBNP for Abbott Systems Linearity LQ Osmolality Control LQ HbA1c Control FD HbA1c Linearity FD BNP Siemens Atellica Linearity FD HbA1c Glycohemoglobin A1c Controls Linearity FD Procalcitonin Linearity LQ Homocysteine Control LQ hs-CRP Linearity LQ Beta-Hydroxybutyric Acid Cal Ver LQ T-Uptake Tosoh AIA Linearity LQ hs-CRP Linearity FD General Chemistry Panel 2 for Ortho Vitros Linearity LQ ASO Linearity LQ Direct TIBC for Ortho Vitros Linearity FD UIBC Linearity FLQ Vitamin D for Ortho Vitros Linearity LQ Homocysteine Siemens Atellica Linearity FD iPTH for Ortho Vitros Linearity FD iPTH Siemens Atellica Linearity FD iPTH for Roche Systems Linearity FD iPTH for Abbott Systems Linearity LQ CRP for Ortho Vitros Linearity LQ Cystatin C Control FLQ Vitamin D Linearity FLQ Anti-Mullerian Hormone for Roche Systems Method Val FD GFAP for bioMerieux VIDAS® TBI (GFAP) Linearity FD Procalcitonin for Siemens Atellica Linearity FLQ Vitamin D Linearity FD Lipoprotein (a) Linearity FLQ Vitamin D for Roche Systems Linearity FLQ HbA1c Method Val FD UCH-L1 for bioMerieux VIDAS® TBI (UCH-L1) Control FD Traumatic Brain Injury (TBI) Linearity FD Lipids Beckman AU Linearity FD Cardiac Markers for Siemens Atellica Linearity FD General Chemistry Beckman AU Linearity FD Cardiac Markers Linearity FD TDM Linearity FD Fertility Siemens Atellica Linearity FD Lipids Linearity FD Anemia Siemens Atellica Control FD Urine Chemistry Linearity FD Urine/Fluids Chemistry Linearity FD Thyroid Siemens Atellica Linearity LQ Ammonia/Ethanol Linearity LQ Protein Control FD Immunoassay Linearity FD Tumor Markers for Siemens Atellica Linearity FD General Chemistry for Roche Systems Control FD BNP Control FD TDM Control FD Assayed Chemistry, Level 1 Control FD Assayed Chemistry, Level 2 Control LQ RF/CRP Linearity FD Bilirubin for Roche Systems Control FD Cardiac Markers Linearity FD Immunoassay Linearity FD Bilirubin Beckman AU Linearity FLQ Fertility for Roche Systems Linearity FD Lipids for Roche Systems Linearity FLQ Thyroids for Roche Systems Linearity LQ RF/CRP Linearity FD Immunoassay for Abbott Systems Linearity FD BNP (Extended) Linearity FD General Chemistry Linearity FD Thyroid for Abbott Systems Linearity FD Tumor Markers Linearity LQ Ammonia/Ethanol for Roche Systems Linearity FLQ Anemia for Roche Systems Linearity FLQ ISE + Trigs Linearity FD General Chemistry Panel 3 for Ortho Vitros Linearity FLQ TDM for Roche Systems Linearity FD General Chemistry Panel 4 for Ortho Vitros Linearity FD General Chemistry Panel 1 for Ortho Vitros Linearity FD General Chemistry Panel 3 for Abbott Systems Linearity FLQ Anemia for Siemens Atellica Linearity FD Cardiac Markers for PATHFAST Immunoanalyzer Linearity FLQ TDM for Ortho Vitros Linearity FD General Chemistry Panel 1 for Abbott Systems Linearity FD General Chemistry Panel 4 for Abbott Systems Linearity FD Cardiac Markers for Roche Systems Linearity FD General Chemistry Panel 2 for Abbott Systems Linearity FD Cardiac Markers for Ortho Vitros Linearity FLQ TDM for Beckman AU Linearity FLQ TDM for Abbott Systems Linearity FD Urine Chemistry Panel 1 for Abbott Systems Linearity FD Urine Chemistry Panel 2 for Abbott Systems Linearity FD General Chemistry Panel 2 for Alfa Wassermann Linearity FD Traumatic Brain Injury (TBI) Linearity LQ Special Proteins Linearity FD GFAP, UCH-L1 for bioMerieux VIDAS® TBI (GFAP, UCH-L1) Control FD GFAP, UCH-L1 for bioMerieux VIDAS® TBI (GFAP, UCH-L1) Linearity FD Tumor Markers for Roche Systems Linearity LQ Ammonia/Ethanol for Abbott Systems Linearity FD Bilirubin Linearity FD ISE for Siemens Atellica Linearity FLQ Fertility Siemens Atellica Linearity FD General Chemistry Panel 3 for Alfa Wassermann Linearity FD Urine Chemistry for Beckman AU Linearity FD Special Diabetes Linearity FD Thryoid for Ortho Vitros Linearity FD General Chemistry Panel 1 for Alfa Wassermann Linearity FD General Chemistry Panel 4 for Alfa Wassermann Linearity LQ Ammonia/Alcohol for Ortho Vitros Linearity FD Tumor Markers for Abbott Systems Linearity FLQ Special Diabetes for Roche Systems Cal Ver LQ Blood Gas

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device