Elecsys IGFBP-3 - Indonesia BPOM Medical Device Registration
Elecsys IGFBP-3 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323116. The device is manufactured by ROCHE DIAGNOSTICS GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ROCHE INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ROCHE DIAGNOSTICS GMBHCountry of Origin
Germany
Authorized Representative
ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
May 23, 2023
Expiry Date
Feb 21, 2028
Product Type
Clinical Chemistry Test System
Human growth hormone test system (kit & cair)
Invitro Diagnostics
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COBAS omni Lysis Reagent
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COBAS omni Specimen Diluent
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