ABBOTT NP-40 - Indonesia BPOM Medical Device Registration
ABBOTT NP-40 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10204024603. The device is manufactured by ABBOTT MOLECULAR INC. from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. SCIENCEWERKE.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 1
Manufacturer
ABBOTT MOLECULAR INC.Country of Origin
United States
Authorized Representative
PT. SCIENCEWERKEAR Address
Jl.Palmerah Barat No.25
Registration Date
May 27, 2024
Expiry Date
Dec 31, 2026
Product Type
Reagents and Specimen Providers
General purpose reagent.
Invitro Diagnostics
DAPI I Counterstain 2x500 ยตl (1000 ng/mL)
Vysis ALK Break Apart FISH Probe Kit
DAPI II Counterstain 2 x 500 ยตL (125 ng/mL)
20X SSC
Vysis Paraffin Pretreatment IV & Post-Hybridization Wash Buffer Kit
ABBOTT RealTime HCV Genotype II Control Kit
Vysis CEP X SpetrumOrange /Y SpectrumGreen DNA Probe Kit
ABBOTT RealTime HCV Genotype II Amplification Reagent Kit
Vysis CLL FISH Probe Kit
PATHVYSION HER-2 DNA Probe Kit
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MGI Nucleic Acid Extraction Kit
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Allplexโข GI-Virus Assay
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AllplexTM GI-Bacteria (I) Assay
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ALLPLEXโข Meningitis-B Assay
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ALLPLEXโข Meningitis-V1 Assay
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ALLPLEXโข Meningitis-V2 Assay
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AllplexTM Respiratory Panel 3
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