TELLGEN SARS-CoV-2 Nucleic Acid Detection Kit Based on Cartridge Real-Time PCR platform- N gene and ORF1ab gene - Indonesia BPOM Medical Device Registration
TELLGEN SARS-CoV-2 Nucleic Acid Detection Kit Based on Cartridge Real-Time PCR platform- N gene and ORF1ab gene is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303124065. The device is manufactured by TELLGEN CORPORATION from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is SETIA GUNA MEDIKA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
TELLGEN CORPORATIONCountry of Origin
China
Authorized Representative
SETIA GUNA MEDIKAAR Address
KOMPLEK TAMAN KEBUN JERUK BLOK AA IV NO. 39-40, KEBUN JERUK, JAKARTA BARAT
Registration Date
Jul 19, 2022
Expiry Date
Dec 31, 2024
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
FORTRESS Salmonella Paratyphi AH
FORTRESS DIAGNOSTICS LTD.
FORTRESS Rheumatoid Factors (RF) Latex Test
FORTRESS DIAGNOSTICS LIMITED
FORTRESS Polyspecific AHG
FORTRESS DIAGNOSTICS LTD
Luminex Sheath Fluid - 20 liters
LUMINEX CORP
LABScan 3D Performance Verification Kit
LUMINEX CORP
LABScan 3D Calibration Kit
LUMINEX CORP
BioCore COVID-19 Fast Real Time PCR Kit
INVITES BIOCORE CO. LTD
Lyophilized Class II Complement
ONE LAMBDA INC.
Fluoroquenchโข Plus Acridine Orange/ Ethidium Bromide โ 100 ml
ONE LAMBDA INC.
LABTYPEโข PE Conjugated Streptavidin
ONE LAMBDA INC.

