MACCURA CA 15-3 (CLIA) - Indonesia BPOM Medical Device Registration
MACCURA CA 15-3 (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320351. The device is manufactured by MACCURA BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. RESINS LABORATORIES.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
MACCURA BIOTECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. RESINS LABORATORIESAR Address
Jl. Raya Bogor Km. 24,6
Registration Date
Nov 24, 2023
Expiry Date
May 17, 2026
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
VIRTUEDX HA Calibrator 5D
VIRTUEDX HA Normal Control 5D
VIRTUEDX HA-50 LH-5 Lysing Reagent A
VIRTUEDX HA-50 LD-5 Lysing Reagent A
VIRTUEDX HA-50 GD-5 Diluent A
VIRTUEDX HA-50 CC-5 Cell Clean A
MACCURA 25-OH Vitamin D Chemiluminescent Immunoassay Kit
VIRTUEDX HA-50 DD-5 Fluorescent Dye A
MACCURA Ferritin (CLIA)
MACCURA 25-OH Vitamin D Control Level 1
MACCURA Ferritin (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA 25-OH Vitamin D Control Level 1
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Testosterone (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA HBsAg (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Total PSA (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Free PSA (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA CA 125 (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA CA 19-9 (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA CEA (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA FSH (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.