TELLGEN Human Methylated Septin9 DNA Detection Kit based on Real-Time PCR Platform (liquid) - Indonesia BPOM Medical Device Registration
TELLGEN Human Methylated Septin9 DNA Detection Kit based on Real-Time PCR Platform (liquid) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320314. The device is manufactured by SANGHAI TELLGEN DIAGNOSIS CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SEGMED DISTRIBUTION INDONESIA.
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
SANGHAI TELLGEN DIAGNOSIS CO., LTD.Country of Origin
China
Authorized Representative
PT. SEGMED DISTRIBUTION INDONESIAAR Address
SEGMED DISTRIBUSI INDONESIA
Registration Date
Oct 15, 2023
Expiry Date
Dec 31, 2025
Product Type
Tumor Antigen Immunologic Test System
Colorectal Neoplasia, Dna Methylation and Hemoglobin Detection test system
Invitro Diagnostics
Fluorobeadsโข T Lymphocyte
ONE LAMBDA INC.
ONE LAMBDA PE-Conjugated Goat Anti-Human IgG
ONE LAMBDA INC.
Fluorobeadsโข B Lymphocyte
ONE LAMBDA INC.
FlowPRAโข Negative Control
ONE LAMBDA INC
FlowPRA โข Class I Positive Control
ONE LAMBDA INC.
LABScan 3D Verification Kit
LUMINEX CORPORATION
LABScreen โข Negative Control
ONE LAMBDA INC.
LABScan 3D Calibration Kit
LUMINEX CORPORATION
Lyophilized Class I Complement
ONE LAMBDA INC.
Lyophilized Class II Complement
ONE LAMBDA INC.

