ALTL - Indonesia BPOM Medical Device Registration
ALTL is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324640. 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
Dec 27, 2023
Expiry Date
Aug 29, 2028
Product Type
Clinical Chemistry Test System
Alanine amino transferase (ALT/SGPT) test system (kit & cair)
Invitro Diagnostics
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ABX Pentra P MultiControl
ELECSYS HBsAg Confirmatory Test
BECKMAN COULTER HbA1c Advanced
Elecsys Anti-SARS-CoV-2 cobas e analyzers
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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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ultraView Universal Alkaline Phosphatase Red Detection Kit
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COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 Systems
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COBAS omni Wash Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Lysis Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Specimen Diluent
ROCHE MOLECULAR SYSTEMS INC.