I-STAT Total Beta - hCG Cartridge - Indonesia BPOM Medical Device Registration
I-STAT Total Beta - hCG Cartridge is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101714170. The device is manufactured by ABBOTT POINT OF CARE CANADA LIMITED. from Canada, 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
ABBOTT POINT OF CARE CANADA LIMITED.Country of Origin
Canada
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 20, 2024
Expiry Date
Jul 01, 2027
Product Type
Clinical Chemistry Test System
Human chorionic gonadotropin (HCG) test system (card)
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