BIOSYSTEMS Anti-Nuclear Antibodies HEp-2 (ANA-HEp-2) - Indonesia BPOM Medical Device Registration
BIOSYSTEMS Anti-Nuclear Antibodies HEp-2 (ANA-HEp-2) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305320679. The device is manufactured by BIOSYSTEMS S.A. from Spain, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. FLEXYLABS INSTRUMENT INDONESIA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
BIOSYSTEMS S.A.Country of Origin
Spain
Authorized Representative
PT. FLEXYLABS INSTRUMENT INDONESIAAR Address
Ruko Poris Garden Blok A9A No.1A
Registration Date
Feb 08, 2023
Expiry Date
Dec 02, 2027
Product Type
Immunological Test System
Antinuclear antibody immunological test system.
Invitro Diagnostics
BIOSYSTEMS RHEUMATOID FACTORS (RF) STANDARD
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BIOSYSTEMS SEROLOGY NEGATIVE CONTROL
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BIOSYSTEMS APOLIPOPROTEIN B (APO B) STANDARD
BIOSYSTEMS HOMOCYSTEINE CONTROL II
BIOSYSTEMS CK-MB CONTROL SERUM II
BIOSYSTEMS HOMOCYSTEINE CONTROL I
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