DIRECT SARS-COV-2 REAL TIME PCR KIT - Indonesia BPOM Medical Device Registration
DIRECT SARS-COV-2 REAL TIME PCR KIT is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420481. The device is manufactured by VIRCELL SL from Spain, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is Nelta Multi Gracia.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
VIRCELL SLCountry of Origin
Spain
Authorized Representative
Nelta Multi GraciaAR Address
Metland Menteng. Jl. Menteng Niaga Blok J7 No.1 Ujung Menteng, Cakung, Jakarta Timur 13960
Registration Date
Sep 27, 2024
Expiry Date
Dec 31, 2026
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
VIRCLIA Auxiliary Reagents-W1
DIPHTHERIA VIRCLIA IgG MONOTEST
AMPLIRUN TOTAL HSV-1/HSV-2/VZV CONTROL EXUDATE
VIRCELL ELISA SORBENT
VIRCELL Transport Medium
VIRCELL MEASLES ELISA IgG/IgM
VIRCELL CYTOMEGALOVIRUS ELISA IgM CAPTURE
VIRCELL CYTOMEGALOVIRUS ELISA IgG
VIRCELL CHLAMYDIA TRACHOMATIS ELISA IgG/IgM
VIRCELL TOXOPLASMA ELISA IgM Capture
VIRCLIA AUXILIARY REAGENTS-EDB
VIRCELL S.L.
INVASIVE CANDIDIASIS (CAGTA) VIRCLIA IgG MONOTEST
VIRCELL S.L.
HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST
VIRCELL S.L
HELICOBACTER PYLORI VIRCLIA® IgG MONOTEST
VIRCELL S.L
HERPES SIMPLEX 1+2 VIRCLIA® IgG MONOTEST
VIRCELL S.L
HELICOBACTER PYLORI VIRCLIA® IgA MONOTEST
VIRCELL S.L
SERION ELISA Control Helicobacter pylori IgG
INSTITUT VIRION\SERION GMBH
SERION ELISA Control Aspergillus fumigatus IgG
INSTITUT VIRION\SERION GMBH
MEASLES VIRCLIA IgM MONOTEST
VIRCELL S.L
RUBELLA VIRCLIA IgM MONOTEST
VIRCELL S.L