SPOTCHEM™ II Inorganic Phosphorus - Indonesia BPOM Medical Device Registration
SPOTCHEM™ II Inorganic Phosphorus is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101911969. The device is manufactured by ARKRAY FACTORY, INC. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ARKRAY.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ARKRAY FACTORY, INC.Country of Origin
Japan
Authorized Representative
PT. ARKRAYAR Address
Gedung Mega Plaza Lt. 12, Jl. HR. Rasuna Said Kav. C - 3
Registration Date
Jan 20, 2025
Expiry Date
Oct 26, 2027
Product Type
Clinical Chemistry Test System
Phosphorus (inorganic) test system (kit & cair)
Invitro Diagnostics
SPOTCHEM II STAT-1 (LDH, CPK, GPT/ALT, GOT/AST, Blood Urea Nitrogen, Total Bilirubin)
SPOTCHEM™ II HDL-Cholesterol (Direct Method)
SPOTCHEM™ II Liver-1 (LDH, GPT/ALT, GOT/AST, Albumin, Total Protein, Total Bilirubin)
SPOTCHEM II Panel-1 (GPT/ALT, GOT/AST, Blood Urea Nitrogen, Glucose, Total Cholesterol, Total Bilirubin)
SPOTCHEM ™ II CPK
SPOTCHEM™ II Amylase
SPOTCHEM II ALP
SPOTCHEM™ II Uric Acid
SPOTCHEM II Blood Urea Nitrogen
SPOTCHEM ™ II GOT/AST
SPOTCHEM™ II Liver-1 (LDH, GPT/ALT, GOT/AST, Albumin, Total Protein, Total Bilirubin)
ARKRAY FACTORY, INC.
SPOTCHEM II Panel-1 (GPT/ALT, GOT/AST, Blood Urea Nitrogen, Glucose, Total Cholesterol, Total Bilirubin)
ARKRAY FACTORY, INC.
SPOTCHEM™ II HDL-Cholesterol (Direct Method)
ARKRAY FACTORY, INC.
SPOTCHEM II STAT-1 (LDH, CPK, GPT/ALT, GOT/AST, Blood Urea Nitrogen, Total Bilirubin)
ARKRAY FACTORY, INC.
SPOTCHEM ™ II CPK
ARKRAY FACTORY, INC.
SPOTCHEM™ II Amylase
ARKRAY FACTORY, INC.
SPOTCHEM II ALP
ARKRAY FACTORY, INC.
COBIO S50 Fully Automated Urine Sediment Analyzer
COBIO SMART HEALTHCARE TECHNOLOGY CO., LTD.
SPOTCHEM™ II Uric Acid
ARKRAY FACTORY, INC.
SPOTCHEM II Blood Urea Nitrogen
ARKRAY FACTORY, INC.