FlowPRA™ Class II Positive Control - Indonesia BPOM Medical Device Registration
FlowPRA™ Class II Positive Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305321295. The device is manufactured by ONE LAMBDA INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SETIA GUNA MEDIKA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ONE LAMBDA INC.Country of Origin
United States
Authorized Representative
PT. SETIA GUNA MEDIKAAR Address
KOMPLEK TAMAN KEBUN JERUK BLOK AA IV NO. 39-40, KEBUN JERUK, JAKARTA BARAT
Registration Date
Dec 19, 2023
Expiry Date
Dec 31, 2024
Product Type
Immunological Test System
Immunological quality control
Invitro Diagnostics
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FlowPRA™ Negative Control
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FORTRESS ANTI - D IgG/IgM Blend
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FORTRESS Anti - B Monoclonal
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FlowPRA ™ Class I Positive Control
ONE LAMBDA INC.