BIOSYSTEMS Prothrombin Time (PT) - Indonesia BPOM Medical Device Registration
BIOSYSTEMS Prothrombin Time (PT) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207124484. The device is manufactured by BIOSYSTEMS S.A from Spain, and is classified as Risk Class Kelas Resiko : C. 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
Haematology Package and Kit
Prothrombin time test.
Invitro Diagnostics
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BIOSYSTEMS Uric Acid
BIOSYSTEMS Creatine Kinase (CK)
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)
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BIOSYSTEMS SEROLOGY NEGATIVE CONTROL
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NEOMEDICA Neo Diluent C
NEOMEDICA D.O.O.
NEOMEDICA Neo U Stain
NEOMEDICA DOO
BIOSYSTEMS Activated Partial Thromboplastin Time (APTT)
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BIOSYSTEMS Fibrinogen Clauss
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BIOSYSTEMS Cholesterol HDL Direct
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BIOSYSTEMS Total Bile Acids
BIOSYSTEMS S.A.
BIOSYSTEMS AMMONIA, ETHANOL, CO2 CONTROL I
BIOSYSTEMS S.A.