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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2019-08-26 |
| Kit, Serological, Positive Control | MJX | Class 1 | Clinical Chemistry | No | 2019-08-08 |
| Enzyme Controls (Assayed And Unassayed) | JJT | Class 1 | Clinical Chemistry | No | 2021-06-07 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2017-05-09 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2017-05-09 |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | Class 1 | Clinical Chemistry | No | 2019-08-08 |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | GOD | Class 1 | Microbiology | No | 2024-11-25 |
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