i-STAT cTnI Control Level 2 - Indonesia BPOM Medical Device Registration
i-STAT cTnI Control Level 2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101222126. 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 TRANSMEDIC INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
CLINIQA CORPORATIONCountry of Origin
United States
Authorized Representative
TRANSMEDIC INDONESIAAR 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
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
COBAS CRP Control cobas b 101
BECKMAN COULTER Serum Protein Multi-Calibrator 1
BECKMAN COULTER ITA Control Serum Level 1
BECKMAN COULTER ITA Control Serum Level 3
i-STAT cTnI Control Level 1
I-STAT CTNI Control Level 3
CLINIQA Liquid QC® Cardiac Marker Control VS
I-STAT CK-MB Calibration Verification Set
i-STAT CK-MB Control Level 1
i-STAT CK-MB Control Level 2
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