QUIDEL TriageTrue High Sensitivity Troponin I Control 1 - Indonesia BPOM Medical Device Registration
QUIDEL TriageTrue High Sensitivity Troponin I Control 1 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221741. The device is manufactured by QUIDEL CARDIOVASCULAR INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BRIDGE TWO.
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
QUIDEL CARDIOVASCULAR INC.Country of Origin
United States
Authorized Representative
PT. BRIDGE TWOAR Address
Petojo Melintang No. 17 Kel. Petojo Selatan, Kec. Gambir Jakarta Pusat
Registration Date
Oct 15, 2022
Expiry Date
Jun 15, 2027
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
TECHNOCLONE AK-Calibrant
TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH
TECHNOCLONE Coagulation Reference
TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS LTD.,
TECHNOCLONE Coagulation Control A
TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS LTD.
TC Thrombin Reagent
TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH
ACTI-LANCE Lite Safety Lancet 28G
HTL-STREFA S.A.
TECHNOCLONE Fibrinogen Reagent Kit
TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH
TC Coagulation Control AK
TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS LTD.
TECHNOCHROM ATIII Kit
TECHNOCLONE MANUFACTURING OF DIAGNOSTICS AND PHARMACEUTICALS GMBH
EPIX Laparoscopic Grasper
APPLIED MEDICAL RESOURCES CORPORATION
MEDISAFE Solo, safety lancets
HTL-STREFA S.A.

