GLORY DIAGNOSTICS – LYSE 3600 - Indonesia BPOM Medical Device Registration
GLORY DIAGNOSTICS – LYSE 3600 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208320538. The device is manufactured by DIRUI INDUSTRIAL CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NOBLE BLESSINGS OF SIPOLIN.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DIRUI INDUSTRIAL CO., LTDCountry of Origin
China
Authorized Representative
PT. NOBLE BLESSINGS OF SIPOLINAR Address
Jl. H. Midi II No.6 Rt.05/ RW.02 Limo Cinere, Depok 16515
Registration Date
Apr 28, 2023
Expiry Date
Apr 25, 2026
Product Type
Hematological Reagents
Red cell lysing reagent.
Invitro Diagnostics
DIRUI Control for Automatic Hematology Analyzer
DIRUI BCC-3600 Hematology Analyzer and Accessories
DIRUI CRP
DIRUI MALB
DIRUI CK-MB
GLORY DIAGNOSTICS – GD227 AUTO HEMATOLOGY ANALYZER AND ACCESSORIES
GLORY DIAGNOSTICS – CLEANSER 3600
GLORY DIAGNOSTICS – GD907PLUS Auto-Chemistry Analyzer and Accessories
DIRUI Mg-XB
DIRUI TIBC
ACCURATE HCV (WB/S/P) CASSETTE
ZHEJIANG ORIENT GENE BIOTECH CO.,LTD.
GLORY DIAGNOSTICS – ANTI HCV STRIP
LINEAR CHEMICALS S.L.U
GLORY DIAGNOSTICS – ANTI HCV CASSETTE
LINEAR CHEMICALS, S.L.U
GLORY DIAGNOSTICS – HBsAg CASSETTE
LINEAR CHEMICALS S.L.U
GLORY DIAGNOSTICS – HBsAg STRIP
LINEAR CHEMICALS S.L.U
GLORY DIAGNOSTICS - MULTICALIBRATOR
LINEAR CHEMICALS S.L.U
GLORY DIAGNOSTICS-GLORY 127 Semi-automatic Biochemistry Analyzer & Accesssories
SINNOWA MEDICAL SCIENCE & TECHNOLOGY COMPANY LIMITED
GLORY DIAGNOSTICS - CHOLINESTERASE
LINEAR CHEMICALS S.L.U
WHEISMAN W-31L Lyse
WHEISMAN MEDICAL TECHNOLOGY CO., LTD.
WHEISMAN W-31D Diluent
WHEISMAN MEDICAL TECHNOLOGY CO., LTD