MACCURA Thyroid autoantibodies Control - Indonesia BPOM Medical Device Registration
MACCURA Thyroid autoantibodies Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324237. 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
Nov 13, 2023
Expiry Date
May 17, 2026
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
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MACCURA HBsAg (CLIA)
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MACCURA CA 15-3 (CLIA)
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MACCURA CEA (CLIA)
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MACCURA CA 19-9 (CLIA)
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MACCURA Free PSA (CLIA)
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