VivaDiag ™ Plus Hemoglobin Meter - Indonesia BPOM Medical Device Registration
VivaDiag ™ Plus Hemoglobin Meter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205320504. The device is manufactured by VIVACHEK BIOTECH (HANGZHOU) CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MACROCITRA ARDANASEJATI.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
VIVACHEK BIOTECH (HANGZHOU) CO., LTDCountry of Origin
China
Authorized Representative
PT. MACROCITRA ARDANASEJATIAR Address
Rukan Taman Meruya Blok M-65 Meruya Ilir - Jakarta Barat Telp. 021-5874575, Fax. 021-5874573
Registration Date
Oct 27, 2023
Expiry Date
Aug 01, 2028
Product Type
Automatic and Semi-Automatic Hematology Equipment
Automated hemoglobin system.
Invitro Diagnostics
VivaDiag Glycosylated Hemoglobin Control Solution
VivaDiag ™ Plus Hemoglobin Testing System
VivaDiag™ Ketamine Test Kit (FIA)
VivaDiag™ Methamphetamine Test Kit (FIA)
VivaDiag Plus Hemoglobin Test Strips
VivaDiag Myoglobin Control Solution (FIA)
VivaDiag ™ Ferritin Control Solution (FIA)
VivaDiag Creatine Kinase-MB Control Solution (FIA)
VivaDiag Triiodothyronine Control Solution (FIA)
VivaDiag Thyroxine Control Solution (FIA)
RIGHTSIGN COC Rapid Test Strip (Urine) 300ng/mL
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RIGHTSIGN COC Rapid Test Cassette (Urine) 300 ng/mL
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RIGHTSIGN BZO Rapid Test Cassette (Urine) 300 ng/ml
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RIGHTSIGN Typhoid Rapid Test Cassette (Serum/Plasma)
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RIGHTSIGN HAV Rapid Test Cassette (Serum/Plasma)
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RIGHTSIGN HCV Rapid Test Cassette (Serum/Plasma)
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RIGHTSIGN HBsAg Rapid Test Cassette (Serum/Plasma)
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RIGHTSIGN AMP Rapid Test Strip (Urine)
HANGZHOU BIOTEST BIOTECH CO., LTD
RIGHTSIGN AMP Rapid Test Cassette (Urine)
HANGZHOU BIOTEST BIOTECH CO., LTD.
RIGHTSIGN THC Rapid Test Strip (Urine)
HANGZHOU BIOTEST BIOTECH CO., LTD.