SIEMENS RAPID QC HCT LEVEL A - Indonesia BPOM Medical Device Registration
SIEMENS RAPID QC HCT LEVEL A is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323398. The device is manufactured by BIONOSTICS, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SIEMENS HEALTHINEERS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BIONOSTICS, INC.Country of Origin
United States
Authorized Representative
PT. SIEMENS HEALTHINEERS INDONESIAAR Address
Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88
Registration Date
Jul 04, 2023
Expiry Date
Mar 04, 2025
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
RAPIDQC Complete Level 1
SIEMENS RAPID QC Complete Level 2
i-STAT TriControls Control Level 1
i-STAT TriControls Calibration Verification Set Levels 1-5
i-STAT TriControls Control Level 3
i-STAT TriControls Control Level 2
RAPID QC PLUS LEVEL 1
RAPIDQC Complete Level 3
ACCU-CHEK Linearity Test Kit
ADVIA Centaur Calibrator D
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
IMMULITE 2000 Systems Allergen Specific IgE Universal Kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
DIMENSION Bilirubin Calibrator (TBI/DBI CAL)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE 2000 3gAllergy Specific IgE Positive Control for D1 &D2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
ADVIA Centaur CA 15-3
SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)
ADVIA Centaur Anti-HBs2 Quality Control (aHBs2 QC)
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
DIMENSION Revised C-Reactive Protein Calibrator (RCRP CAL)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
ADVIA Centaur Insulin (IRI)
MINARIS MEDICAL CO., LTD.
CLINITEK Status+ Analyzer and Accessories
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
IMMULITE 2000 IGF-I
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

