BIOSYSTEMS Creatine Kinase (CK) - Indonesia BPOM Medical Device Registration
BIOSYSTEMS Creatine Kinase (CK) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101124492. The device is manufactured by BIOSYSTEMS S.A from Spain, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ELGA TAMA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BIOSYSTEMS S.ACountry of Origin
Spain
Authorized Representative
ELGA TAMAAR Address
JL. RASAMALA RAYA NO. 12 D RT. 006 RW. 003 KELURAHAN JATIPULO, KECAMATAN PALMERAH
Registration Date
Jul 26, 2021
Expiry Date
Dec 24, 2025
Product Type
Clinical Chemistry Test System
Creatine phosphokinase/creatine kinase or isoenzymes test system(kit & cair)
Invitro Diagnostics
BIOSYSTEMS Biochemistry Control Serum I
BIOSYSTEMS Biochemistry Control Serum II
BIOSYSTEMS Cholesterol LDL Direct
BIOSYSTEMS Uric Acid
BIOSYSTEMS Prothrombin Time (PT)
BIOSYSTEMS Aspartate Aminotransferase (AST/GOT)
BIOSYSTEMS Glucose
BIOSYSTEMS CREATININE
BIOSYSTEMS Biochemistry Control Serum II (Human)
BIOSYSTEMS Cholinesterase (CHE)
BIOSYSTEMS CARBON DIOXIDE (CO2)
BIOSYSTEMS S.A.
BIOSYSTEMS APOLIPOPROTEIN B (APO B)
BIOSYSTEMS S.A.
BIOSYSTEMS SEROLOGY NEGATIVE CONTROL
BIOSYSTEMS S.A.
NEOMEDICA Neo Diluent C
NEOMEDICA D.O.O.
NEOMEDICA Neo U Stain
NEOMEDICA DOO
BIOSYSTEMS Activated Partial Thromboplastin Time (APTT)
BIOSYSTEMS S.A.
BIOSYSTEMS Fibrinogen Clauss
BIOSYSTEMS S.A.
BIOSYSTEMS Cholesterol HDL Direct
BIOSYSTEMS S.A.
BIOSYSTEMS Total Bile Acids
BIOSYSTEMS S.A.
BIOSYSTEMS AMMONIA, ETHANOL, CO2 CONTROL I
BIOSYSTEMS S.A.