ADAMS™ A1c HA-8180T - Indonesia BPOM Medical Device Registration
ADAMS™ A1c HA-8180T is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207914481. 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
May 16, 2023
Expiry Date
Oct 26, 2027
Product Type
Haematology Package and Kit
Glycosylated hemoglobin assay.
Invitro Diagnostics
SPOTCHEM II Panel-1 (GPT/ALT, GOT/AST, Blood Urea Nitrogen, Glucose, Total Cholesterol, Total Bilirubin)
SPOTCHEM™ II Liver-1 (LDH, GPT/ALT, GOT/AST, Albumin, Total Protein, Total Bilirubin)
SPOTCHEM™ II HDL-Cholesterol (Direct Method)
SPOTCHEM II STAT-1 (LDH, CPK, GPT/ALT, GOT/AST, Blood Urea Nitrogen, Total Bilirubin)
SPOTCHEM ™ II CPK
SPOTCHEM™ II Amylase
SPOTCHEM II ALP
SPOTCHEM™ II Inorganic Phosphorus
SPOTCHEM™ II Uric Acid
SPOTCHEM II Blood Urea Nitrogen
SPOTCHEM™ II Liver-1 (LDH, GPT/ALT, GOT/AST, Albumin, Total Protein, Total Bilirubin)
ARKRAY FACTORY, INC.
SPOTCHEM II STAT-1 (LDH, CPK, GPT/ALT, GOT/AST, Blood Urea Nitrogen, 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 CPK
ARKRAY FACTORY, INC.
SPOTCHEM™ II Amylase
ARKRAY FACTORY, INC.
SPOTCHEM II ALP
ARKRAY FACTORY, INC.
SPOTCHEM™ II Inorganic Phosphorus
ARKRAY FACTORY, INC.
COBIO S50 Fully Automated Urine Sediment Analyzer
COBIO SMART HEALTHCARE TECHNOLOGY CO., LTD.
SPOTCHEM™ II Uric Acid
ARKRAY FACTORY, INC.