Simplexa™ Dengue - Indonesia BPOM Medical Device Registration
Simplexa™ Dengue is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303910680. The device is manufactured by DIASORIN MOLECULAR LLC from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is NELTA MULTI GRACIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DIASORIN MOLECULAR LLCCountry of Origin
United States
Authorized Representative
NELTA MULTI GRACIAAR Address
Metland Menteng. Jl. Menteng Niaga Blok J7 No.1 Ujung Menteng, Cakung, Jakarta Timur 13960
Registration Date
Sep 08, 2021
Expiry Date
Dec 31, 2024
Product Type
Serological Reagents
Dengue virus nucleic acid amplification test reagents
Invitro Diagnostics
FOCUS DIAGNOSTICS Rickettsia IFA IgM
SIMPLEXA™ HSV 1&2 Positive Control Pack
SIMPLEXA COVID-19 DIRECT
Simplexa Spectral Calibration Panel
Simplexa Flu A/B & RSV Positive Control Pack
SIMPLEXA™ HSV 1&2 Direct
SIMPLEXA Congenital CMV Positive Control Pack
Simplexa Flu A/B & RSV Direct Gen II
SIMPLEXA Congenital CMV Direct
Dengue Virus IgG DxSelect™
SIMPLEXA COVID-19 DIRECT
DIASORIN MOLECULAR LLC
SIMPLEXA ™ COVID-19 Positive Control Pack
DIASORIN MOLECULAR LLC.
Dengue NS1 Antigen DxSelect
INBIOS INTERNATIONAL, INC.
Simplexa Spectral Calibration Panel
DIASORIN MOLECULAR LLC
Simplexa Flu A/B & RSV Positive Control Pack
DIASORIN MOLECULAR LLC
Simplexa Flu A/B & RSV Direct Gen II
DIASORIN MOLECULAR LLC
Dengue Virus IgM Capture DxSelect™
DIASORIN MOLECULAR LLC.
Dengue Virus IgG DxSelect™
DIASORIN MOLECULAR LLC
SIMPLEXA Congenital CMV Direct
DIASORIN MOLECULAR LLC
FOCUS DIAGNOSTICS Rickettsia IFA IgG
DIASORIN MOLECULAR LLC.