SIMPLEXA™ HSV 1&2 Direct - Indonesia BPOM Medical Device Registration
SIMPLEXA™ HSV 1&2 Direct is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303321248. 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 PT. NELTA MULTI GRACIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DIASORIN MOLECULAR LLCCountry of Origin
United States
Authorized Representative
PT. NELTA MULTI GRACIAAR Address
Metland Menteng. Jl. Menteng Niaga Blok J7 No.1 Ujung Menteng, Cakung, Jakarta Timur 13960
Registration Date
Sep 20, 2024
Expiry Date
Dec 31, 2027
Product Type
Serological Reagents
Herpes simplex virus serological assays.
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 Congenital CMV Positive Control Pack
Simplexa Flu A/B & RSV Direct Gen II
Dengue Virus IgG DxSelect™
SIMPLEXA Congenital CMV Direct
Simplexa™ Dengue
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