VivaDiag ™ Plus Hemoglobin Testing System - Indonesia BPOM Medical Device Registration
VivaDiag ™ Plus Hemoglobin Testing System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205320491. 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
Feb 01, 2024
Expiry Date
Aug 01, 2028
Product Type
Automatic and Semi-Automatic Hematology Equipment
Automated hemoglobin system (for reagent & control)
Invitro Diagnostics
VivaDiag Glycosylated Hemoglobin Control Solution
VivaDiag™ Ketamine Test Kit (FIA)
VivaDiag™ Methamphetamine Test Kit (FIA)
VivaDiag ™ Plus Hemoglobin Meter
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
HANGZHOU BIOTEST BIOTECH CO., LTD.
RIGHTSIGN COC Rapid Test Cassette (Urine) 300 ng/mL
HANGZHOU BIOTEST BIOTECH CO., LTD.
RIGHTSIGN BZO Rapid Test Cassette (Urine) 300 ng/ml
HANGZHOU BIOTEST BIOTECH CO., LTD.
RIGHTSIGN Typhoid Rapid Test Cassette (Serum/Plasma)
HANGZHOU BIOTEST BIOTECH CO., LTD.
RIGHTSIGN HAV Rapid Test Cassette (Serum/Plasma)
HANGZHOU BIOTEST BIOTECH, CO., LTD.
RIGHTSIGN HCV Rapid Test Cassette (Serum/Plasma)
HANGZHOU BIOTEST BIOTECH CO., LTD.
RIGHTSIGN HBsAg Rapid Test Cassette (Serum/Plasma)
HANGZHOU BIOTEST BIOTECH CO., LTD.
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.