TRUENAT™ MTB-RIF Dx - Indonesia BPOM Medical Device Registration
TRUENAT™ MTB-RIF Dx is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220166. The device is manufactured by MOLBIO DIAGNOSTICS PRIVATE LIMITED from India, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. INDONESIAN DIAGNOSTIC NORMS.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
MOLBIO DIAGNOSTICS PRIVATE LIMITEDCountry of Origin
India
Authorized Representative
PT. INDONESIAN DIAGNOSTIC NORMSAR Address
JALAN KRT RADJIMAN WIDYODININGRAT NO.A23 RT.001 RW.009 KELURAHAN JATINEGARA
Registration Date
Feb 20, 2024
Expiry Date
Mar 30, 2025
Product Type
Serological Reagents
Mycobacterium tuberculosis immunofluorescent reagents.
Invitro Diagnostics
TRUENAT Positive Control Kit - Panel I
Trueprep™ AUTO Universal Sample Pre-treatment Pack
TRUENAT™ MTB Plus
Truelab™ Quattro Real Time Quantitative micro PCR Analyzer and Accessories
Truelab™ Duo Real Time Quantitative Micro PCR Analyzer and Accessories
Truenat™ Universal Control Kit
Truenat™ Salmonella
Truenat™ Dengue/Chikungunya
Truenat™ HPV-HR
WIENER LAB e32 Automated ESR System and Accessories
WIENER LABORATORIES S.A.I.C.
Trueprep™ AUTO Universal Sample Pre-treatment Pack
MOLBIO DIAGNOSTICS PRIVATE LIMITED
TRUEPREP AUTO MTB Sample Pre-Treatment Pack
MOLBIO DIAGNOSTICS PVT. LTD.
TRUENAT™ MTB Plus
MOLBIO DIAGNOSTICS PRIVATE LIMITED
TRUENAT MTB
MOLBIO DIAGNOSTICS PVT. LTD.
FIRST RESPONSE Syphilis Anti-TP Card Test
PREMIER MEDICAL CORPORATION PRIVATE LIMITED
BIOGNOST EA 31 Reagent, Pap 3A
BIOGNOST D.O.O.
BioGnost ® 4% NB Formaldehyde
BIOGNOST D.O.O.
BioGnost Gram Decolorizer Solution 2
BIOGNOST D.O.O.
BioGnost Gram Lugol Solution, Stabilized
BIOGNOST D.O.O.