Pure Global
c989750e9c90527f46a65ed075c460b4

iChroma Anti-CCP

BODITECH WITH INC.·II·Ecuador ARCSA·Registered September 28, 2018
Device classification
Risk class
II
Product type
In Vitro Diagnostic
Brand name
iChroma
Commercial name
19-173 IVD Reagents/Kits, Immunoassay, Autoimmune
Sterilization method
METHODOLOGY: INMUNOANALISIS
Registration information
Analysis ID
c989750e9c90527f46a65ed075c460b4
Registration date
September 28, 2018
Expiration date
September 28, 2023
Creation date
September 28, 2018
Manufacturer
Name
BODITECH WITH INC.
City
CHUNCHEON
Country
KOREA, REPUBLIC OF
Address
43, GEODUDANJI 1-GILL, DONGNAE-MYEON, CHUNCHEON-SI
Product owner
Name
BODITECH WITH INC.
Country
KOREA, REPUBLIC OF
Authorized representative
Name
RAPIDIAGNOSTICS S.A.
Address
ALBORADA, VIII ETAPA, MANZANA 832, SOLAR 5
Phone
42233672
Product use

QUALITATIVE OR SEMIQUANTITATIVE DETERMINATION OF IGG TO CITRULLINATED CYCLIC PEPTIDES (PCC) IN HUMAN BLOOD, SERUM, PLASMA

About this record

Access comprehensive regulatory information for iChroma Anti-CCP in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID c989750e9c90527f46a65ed075c460b4 and manufactured by BODITECH WITH INC.. The device was registered on September 28, 2018.

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.