StatStrip Hb/Hct Control Level 2 - Indonesia BPOM Medical Device Registration
StatStrip Hb/Hct Control Level 2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208913649. The device is manufactured by NOVA BIOMEDICAL CORP. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. TAMARA OVERSEAS CORPORINDO.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
NOVA BIOMEDICAL CORP.Country of Origin
United States
Authorized Representative
PT. TAMARA OVERSEAS CORPORINDOAR Address
Jl. Pinangsia Timur No. 49 Jakarta 11110
Registration Date
Sep 27, 2022
Expiry Date
Feb 09, 2027
Product Type
Hematological Reagents
Hematology quality control mixture.
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