Elecsys FSH - Indonesia BPOM Medical Device Registration
Elecsys FSH is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421562. The device is manufactured by ROCHE DIAGNOSTICS (SUZHOU) LTD from China, 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 (SUZHOU) LTDCountry of Origin
China
Authorized Representative
ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Aug 19, 2024
Expiry Date
Oct 10, 2028
Product Type
Clinical Chemistry Test System
Follicle-stimulating hormone test system (kit & cair)
Invitro Diagnostics
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Elecsys Myoglobin
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PreciControl Maternal Care
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COAGUCHEK aPTT Test
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ROCHE TROP T Sensitive, Troponin T
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COBAS BM - Lactate
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ultraView Universal Alkaline Phosphatase Red Detection Kit
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COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 Systems
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Wash Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Lysis Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Specimen Diluent
ROCHE MOLECULAR SYSTEMS INC.