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fb43e7474e7c75f75a2d39d1315e46e7

Access C- Peptide Calibrators

BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LDT·II·Ecuador ARCSA·Registered August 18, 2022
Device classification
Risk class
II
Product type
In Vitro Diagnostic
Brand name
Access
Commercial name
19-126.- Reagents/Kits for IVD Assays, Immunoassay, Diabetes, C-Peptide
Registration information
Analysis ID
fb43e7474e7c75f75a2d39d1315e46e7
Registration date
August 18, 2022
Expiration date
August 18, 2027
Manufacturer
Name
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LDT
City
SUZHUO, P.R. CHINA
Country
CHINA
Address
181 WEST SU HONG ROAD, SUZHUO INDUSTRIAL PARK, SUZHOU, P.R. CHINA, 215021
Product owner
Name
BECKMAN COULTER, INC.
Country
UNITED STATES
Authorized representative
Name
HEALTH SYSTEMS ROCARSYSTEM S.A.
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680
Product use

C ACCESS PEPTIDE CALIBRATORS ARE INTENDED TO CALIBRATE THE C ACCESS PEPTIDE ASSAY FOR THE DETERMINATION QUANTITATIVE LEVELS OF PEPTIDE C IN HUMAN SERUM, PLASMA AND URINE USING IMMUNOASSAY SYSTEMS ACCESS.

About this record

Access comprehensive regulatory information for Access C- Peptide Calibrators in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID fb43e7474e7c75f75a2d39d1315e46e7 and manufactured by BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LDT. The device was registered on August 18, 2022.

This page provides complete registration details including product type (In Vitro Diagnostic), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.