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Access C- Peptide - ARCSA Registration 832ddb13bcf63f7433281c0cc9bcf737

Access comprehensive regulatory information for Access C- Peptide in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 832ddb13bcf63f7433281c0cc9bcf737 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.

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ARCSA Official Data
II
832ddb13bcf63f7433281c0cc9bcf737
Access C- Peptide
ARCSA ID: 832ddb13bcf63f7433281c0cc9bcf737
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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
832ddb13bcf63f7433281c0cc9bcf737
Registration Date
August 18, 2022
Expiration Date
August 18, 2027
Product Use

THE C ACCESS PEPTIDE ASSAY IS A PARAMAGNETIC PARTICLE CHEMILUMINESCENCE IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF PEPTIDE C IN HUMAN SERUM, PLASMA OR URINE, FOR USE WITH HUMAN ACCESS IMMUNOASSAY AS AN AID TO DIAGNOSE PATIENTS WITH DIABETES OR SUSPECTED DIABETES AND OTHER DISORDERS IN INSULIN SECRETION

Manufacturer
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
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680