MACCURA SARS-CoV-2 IgG (CLIA) - Indonesia BPOM Medical Device Registration
MACCURA SARS-CoV-2 IgG (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303127314. The device is manufactured by MACCURA BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. 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
Sep 01, 2022
Expiry Date
Mar 31, 2025
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
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 25-OH Vitamin D Control Level 1
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Ferritin (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Testosterone (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Total PSA (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA CA 15-3 (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA HBsAg (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA CEA (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA CA 19-9 (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA CA 125 (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Free PSA (CLIA)
MACCURA BIOTECHNOLOGY CO., LTD.