CONTOUR™ TS Control Solution Low - Indonesia BPOM Medical Device Registration
CONTOUR™ TS Control Solution Low is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101126837. 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. TWO NI ROHA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BIONOSTICS INC.Country of Origin
United States
Authorized Representative
PT. TWO NI ROHAAR Address
Satrio Tower Building Lantai 22-24 Jalan Prof. Dr. Kav C4 No 5 Kuningan Timur Setia Budi - Jakarta Selatan 12950
Registration Date
Nov 11, 2021
Expiry Date
Dec 31, 2025
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
Cobas® GLU Linearity Kit
COMBITROL Plus B Level 3
MEDISENSE Glucose & Ketone Control Solutions
ACCU-CHEK Performance Control
ISETROL Level 1, 2, 3
COMBITROL Plus B Level 1
COMBITROL Plus B Level 2
Cobas® GLU QC Kit
ONETOUCH Verio ™ Low Control Solution Hospital
ACCU-CHEK Instant Control
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