A BIOSYSTEMS Bilirubin (Total) - Indonesia BPOM Medical Device Registration
A BIOSYSTEMS Bilirubin (Total) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101811905. 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 PT. ELGA TAMA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BIOSYSTEMS S.A.Country of Origin
Spain
Authorized Representative
PT. ELGA TAMAAR Address
JL. RASAMALA RAYA NO. 12 D RT. 006 RW. 003 KELURAHAN JATIPULO, KECAMATAN PALMERAH
Registration Date
Jul 10, 2021
Expiry Date
Jul 27, 2025
Product Type
Clinical Chemistry Test System
Bilirubin (total or direct) test system (kit & cair)
Invitro Diagnostics
BIOSYSTEMS RHEUMATOID FACTORS (RF) STANDARD
BIOSYSTEMS APOLIPOPROTEIN B (APO B)
BIOSYSTEMS CARBON DIOXIDE (CO2)
BIOSYSTEMS Homocysteine Standards
BIOSYSTEMS SEROLOGY NEGATIVE CONTROL
BIOSYSTEMS FIBRINOGEN CONTROL PLASMA
BIOSYSTEMS APOLIPOPROTEIN B (APO B) STANDARD
BIOSYSTEMS HOMOCYSTEINE CONTROL II
BIOSYSTEMS CK-MB CONTROL SERUM II
BIOSYSTEMS HOMOCYSTEINE CONTROL I
BIOSYSTEMS RHEUMATOID FACTORS (RF) STANDARD
BIOSYSTEMS S.A.
BIOSYSTEMS Homocysteine Standards
BIOSYSTEMS S.A.
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