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i-STAT TriControls Calibration Verification Set Levels 1-5 - Indonesia BPOM Medical Device Registration

i-STAT TriControls Calibration Verification Set Levels 1-5 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324444. 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. TRANSMEDIC INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
i-STAT TriControls Calibration Verification Set Levels 1-5
Analysis ID: AKL 20101324444

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIONOSTICS, INC.

Country of Origin

United States

Authorized Representative

PT. TRANSMEDIC INDONESIA

AR Address

PERKANTORAN MENARA ERA UNIT G-01, JL. SENEN RAYA NO. 135-137

Registration Date

Dec 07, 2023

Expiry Date

Jul 01, 2027

Product Type

Clinical Chemistry Test System

Quality control material (assayed and unassayed) (cair)

Invitro Diagnostics

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