MKCELLS Lactate Dehydrogenase (LDH) Assay Kit (Lactic Acid Substrates Method) - Indonesia BPOM Medical Device Registration
MKCELLS Lactate Dehydrogenase (LDH) Assay Kit (Lactic Acid Substrates Method) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323306. The device is manufactured by BEIJING STRONG BIOTECHNOLOGIES, INC. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INTERSKALA SEHAT SEJAHTERA.
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. INTERSKALA SEHAT SEJAHTERAAR Address
INTERSKALA SEHAT SEJAHTERA
Registration Date
Jun 19, 2023
Expiry Date
Sep 13, 2025
Product Type
Clinical Chemistry Test System
Lactate dehydrogenase test system (kit & cair)
Invitro Diagnostics
Gcell Anti-IgG Coombs Card (Microcolumn Gel Method)
Gcell Liss Coombs (Anti IgG+C3d) 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 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)
MKCELLS Bicarbonate B
TIANJIN TAISHIKANG PHARMACEUTICAL TECHNOLOGY CO., LTD.
MKCELLS CA-150 Auto Chemistry Analyzer and Accessories
SHENZHEN HETO MEDICAL TECH CO.,LTD.
MKCELLS Hollow Fiber Dialyzer
SHANDONG WEIGAO BLOOD PURIFICATION PRODUCTS CO., LTD.
MKCELLS A.V. Fistula Needle Sets
SHANDONG WEIGAO BLOOD PURIFICATION PRODUCTS CO., LTD.
MKCELLS Hematology Analyzer Control (Level 1)
MACCURA BIOTECHNOLOGY CO., LTD.
MKCELLS Hematology Analyzer Calibrator
MACCURA BIOTECHNOLOGY CO., LTD.
MKCELLS Hematology Analyzer Control (Level 2)
MACCURA BIOTECHNOLOGY CO., LTD.
MKCELLS Hematology Analyzer Control (Level 3)
MACCURA BIOTECHNOLOGY CO., LTD.
MKCELLS Disposable Blood Specimen Collection Needle
JIANGSU KANGJIE MEDICAL DEVICES CO., LTD.
MKCELLS Disposable Butterfly Blood Collection Needle
JIANGSU KANGJIE MEDICAL DEVICES CO., LTD.