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I-STAT ACT Control Level 1 - Indonesia BPOM Medical Device Registration

I-STAT ACT Control Level 1 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208818214. The device is manufactured by CLINIQA CORPORATION. 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 ACT Control Level 1
Analysis ID: AKL 20208818214

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. TRANSMEDIC INDONESIA

AR Address

Perkantoran Menara Era Unit G-01 JL.Senen Raya No.135-137 RT 00 RW 00, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Senen, Kel. Senen

Registration Date

Feb 05, 2024

Expiry Date

Jul 01, 2027

Product Type

Hematological Reagents

Hematology quality control mixture.

Invitro Diagnostics

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