SPOTCHEM II GGT - Indonesia BPOM Medical Device Registration
SPOTCHEM II GGT is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101911967. 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 ARKRAY.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ARKRAY FACTORY, INC.Country of Origin
Japan
Authorized Representative
ARKRAYAR Address
Gedung Mega Plaza Lt. 12, Jl. HR. Rasuna Said Kav. C - 3
Registration Date
Dec 20, 2022
Expiry Date
Oct 26, 2027
Product Type
Clinical Chemistry Test System
Gamma-glutamyl transpeptidase and isoenzymes test system (strip & midstream)
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
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