Gcell Liss Coombs (Anti IgG+C3d) Card (Microcolumn Gel Method) - Indonesia BPOM Medical Device Registration
Gcell Liss Coombs (Anti IgG+C3d) Card (Microcolumn Gel Method) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209320641. The device is manufactured by BEIJING STRONG BIOTECHNOLOGIES, INC. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SUMIFIN CITRA ABADI.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
BEIJING STRONG BIOTECHNOLOGIES, INC.Country of Origin
China
Authorized Representative
PT. SUMIFIN CITRA ABADIAR Address
Jl. Alam Sutera Boulevard Alam Sutera Town Center (ASTC) Blok 10D No.19, Kel. Pakulonan, Kec. Serpong Utara - Tangerang Selatan 15325
Registration Date
Dec 04, 2024
Expiry Date
Sep 19, 2027
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Automated blood grouping and antibody test system.
Invitro Diagnostics
Gcell Anti-IgG Coombs Card (Microcolumn Gel Method)
Gcell ABO/RhD Neutral Blood Grouping Card (Microcolumn Gel Method)
Gcell ABO/RhD Blood Grouping Card (Microcolumn Gel Method)
Gcell ABD Blood Grouping Card (Microcolumn Gel Method)
MKCELLS Lactate Dehydrogenase (LDH) Assay Kit (Lactic Acid Substrates Method)
MKCELLS Albumin (ALB) Assay Kit (Bromocresol Green Method)
MKCELLS Total Protein (TP) Assay Kit (Biuret Method)
MKCELLS Urea Assay Kit (Urease-glutamate Dehydrogenase Method)
MKCELLS Glutamate Oxaloacetate Transaminase (GOT/AST) Assay Kit (Aspartic acid substrate method)
MKCELLS Glutamate Pyruvate Transaminase (GPT/ALT) Assay Kit (Alanine substrate method)
DIAFIN DFRC-24A Refrigerated Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,
DIAFIN DFLC-22 Low Speed Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,
DIAFIN DFLC-30 Clinical Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,
ZENIX Glycated Hemoglobin Test kit (HPLC)
SHENZHEN XILAIHENG MEDICAL ELECTRONICS CO., LTD.
DIAFIN DFRC-12A Refrigerated Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,
DIAFIN DFRC-12B Refrigerated Centrifuge and Accessories
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,
INNODX TSH CMIA
XIAMEN INNODX BIOTECH CO., LTD.
ZELL-ESR Erythrocyte Sedimentation Rate Analyzer
STERILE SAFEQUIP AND CHEMICALS LLP
KEWEI RV-IgM Test Kit
BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
DIAFIN DFGC-23 Blood Gel Cards Centrifuge
CHANGSHA YINGTAI INSTRUMENT CO. LTD.,