LABScreen ™ Negative Control - Indonesia BPOM Medical Device Registration
LABScreen ™ Negative Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305520049. 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. 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
ONE LAMBDA INC.Country of Origin
United States
Authorized Representative
PT. SEGMED DISTRIBUTION INDONESIAAR Address
SEGMED DISTRIBUSI INDONESIA
Registration Date
Jan 23, 2025
Expiry Date
Dec 31, 2027
Product Type
Immunological Test System
Immunological quality control
Invitro Diagnostics
Fluorobeads™ T Lymphocyte
ONE LAMBDA PE-Conjugated Goat Anti-Human IgG
Fluorobeads™ B Lymphocyte
FlowPRA ™ Class I Positive Control
LABType PE Conjugated Streptavidin
Lyophilized Class I Complement
Lyophilized Class II Complement
ONE LAMBDA Terasaki HLA Class I Asian Dry Tissue Typing Tray
LABScreen Single Antigen HLA Class I - Combi
FluoroQuench™ Plus Acridine Orange Ethidium Bromide
Fluorobeads™ T Lymphocyte
ONE LAMBDA INC.
ONE LAMBDA PE-Conjugated Goat Anti-Human IgG
ONE LAMBDA INC.
Fluorobeads™ B Lymphocyte
ONE LAMBDA INC.
FlowPRA™ Negative Control
ONE LAMBDA INC
FlowPRA ™ Class I Positive Control
ONE LAMBDA INC.
LABScan 3D Verification Kit
LUMINEX CORPORATION
Lyophilized Class II Complement
ONE LAMBDA INC.
Lyophilized Class I Complement
ONE LAMBDA INC.
LABScan 3D Calibration Kit
LUMINEX CORPORATION
ONE LAMBDA Terasaki HLA Class I Asian Dry Tissue Typing Tray
ONE LAMBDA INC.