Linearity FD General Chemistry Panel 1 for Alfa Wassermann

Registration Details

Registration Name: AALTO SCIENTIFIC LTD.
Registration Number: 3011325031
FEI Number: 3011325031
Status: Active
Expiry Year: 2025
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
Multi-Analyte Controls, All Kinds (Assayed)	JJY	Class 1	Clinical Chemistry	No	2017-05-09

Proprietary Names

Linearity FD General Chemistry Panel 1 for Alfa Wassermann Linearity FD General Chemistry Panel 3 for Alfa Wassermann Control FD TDM Linearity LQ Ammonia/Ethanol for Roche Systems Linearity FD Lipids Linearity FD Tumor Markers Linearity FD General Chemistry Linearity FD Bilirubin Beckman AU Linearity FD Urine/Fluids Chemistry Linearity FD Immunoassay for Abbott Systems Control LQ RF/CRP Linearity LQ ISE Linearity FD Anemia Siemens Atellica Control FD Assayed Chemistry, Level 2 Control FD Urine Chemistry Linearity FD General Chemistry for Roche Systems Linearity FLQ TDM for Roche Systems Linearity FD General Chemistry Panel 4 for Ortho Vitros Linearity FD General Chemistry Panel 3 for Ortho Vitros Linearity FD Lipids Beckman AU Linearity FLQ Special Diabetes for Roche Systems Linearity FLQ Thyroids for Roche Systems Linearity FD Cardiac Markers Siemens Atellica/Centaur Linearity FD Tumor Markers for Siemens Atellica/Centaur Control FD Assayed Chemistry, Level 1 Linearity FD Cardiac Markers Linearity FD TDM Linearity FD Fertility Siemens Centaur Linearity LQ Protein Linearity FD Bilirubin for Roche Systems Linearity FLQ Fertility for Roche Systems Linearity FLQ Anemia for Roche Systems Control FD Immunoassay Linearity FD Immunoassay Control FD Cardiac Markers Linearity FD Thyroid for Abbott Systems Linearity LQ Ammonia/Ethanol Linearity FD Lipids for Roche Systems Linearity LQ RF/CRP Linearity FD General Chemistry Beckman AU Linearity FD General Chemistry Panel 1 for Ortho Vitros Linearity FD BNP (Extended) Control FD BNP Linearity FD Thyroid Siemens Atellica/Centaur Linearity FLQ Anemia for Siemens Atellica/Centaur Linearity FLQ Special Diabetes for Abbott Systems Linearity FLQ Anemia for Abbott Systems Linearity FLQ Fertility for Abbott Systems Linearity FLQ TDM for Beckman AU Linearity FD Cardiac Markers for Roche Systems Linearity FLQ ISE + Trigs for Siemens Dimension Linearity FLQ TDM for Abbott Systems Linearity FD General Chemistry Panel 1 for Abbott Systems Linearity FLQ Urine/Fluids Chemistry for Beckman AU Linearity FD General Chemistry Panel 4 for Abbott Systems Linearity FD Cardiac Markers for PATHFAST Immunoanalyzer Linearity FD General Chemistry Panel 3 for Abbott Systems Linearity FD General Chemistry Panel 2 for Abbott Systems Linearity FD Cardiac Markers for Ortho Vitros Linearity FLQ TDM for Ortho Vitros Linearity FLQ Fertility Siemens Atellica/Centaur Linearity FD Special Diabetes Linearity FLQ Cardiac Markers for Roche Systems Linearity FLQ Cardiac Markers for Ortho Vitros Linearity FD Urine Chemistry Panel 2 Linearity FD Urine Chemistry Panel 1 Control FD GFAP, UCH-L1 for bioMerieux VIDAS® TBI (GFAP, UCH-L1) Linearity FD General Chemistry Panel 2 for Alfa Wassermann Linearity LQ Special Proteins Linearity FD Bilirubin Linearity LQ Ammonia/Ethanol for Abbott Systems Linearity LQ Ammonia/Alcohol for Ortho Vitros Linearity FD GFAP, UCH-L1 for bioMerieux VIDAS® TBI (GFAP, UCH-L1) Linearity FD General Chemistry Panel 4 for Alfa Wassermann Linearity FD Traumatic Brain Injury (TBI)

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device