ULTRA LCS (Predilute) - Indonesia BPOM Medical Device Registration
ULTRA LCS (Predilute) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10201320485. The device is manufactured by ROCHE DIAGNOSTICS (SUZHOU) LTD from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. ROCHE INDONESIA.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
ROCHE DIAGNOSTICS (SUZHOU) LTDCountry of Origin
China
Authorized Representative
PT. ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Jun 13, 2023
Expiry Date
Apr 12, 2028
Product Type
Biological Dyes
Immunohistochemistry reagents and kits (Qualitative).
Invitro Diagnostics
ELECSYS HCG+ฮฒ
VENTANA Bluing Reagent
Elecsys T3
Elecsys FSH
Elecsys Tg II
Elecsys FT3 III
Elecsys T4
COBAS Elecsys Free PSA
ELECSYS HE4 Elecsys and cobas e analyzers
Elecsys Myoglobin
COBAS PreciControl CMV IgG Avidity Elecsys and cobas e analyzers
ROCHE DIAGNOSTICS GMBH.
COBAS MPXV
ROCHE MOLECULAR SYSTEMS, INC.
COBAS CREP2 Creatinine Plus ver.2 COBAS INTEGRA / cobas c systems
ROCHE DIAGNOSTICS GMBH.
COAGUCHEK PT Test
ROCHE DIAGNOSTICS GMBH.
COBAS S2 Fluid Pack
ROCHE DIAGNOSTICS INTERNATIONAL, LTD.
ROCHE Cardiac POC Troponin T 2-Level Control
ROCHE DIAGNOSTICS GMBH
COBAS Elecsys CA 15-3 ll Elecsys and cobas e analyzer
ROCHE DIAGNOSTICS GMBH.
COBAS u 601 Urine Analyzer and Accessories
77 ELECTRONICS INSTRUMENT INDUSTRY LTD.
ISE Reference Electrolyte Roche / Hitachi cobas c
ROCHE DIAGNOSTICS GMBH.
COBAS Insulin CalSet Elecsys and cobas e analyzers
ROCHE DIAGNOSTICS GMBH.