BIOLYZER Precision Check - Indonesia BPOM Medical Device Registration
BIOLYZER Precision Check is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101912855. The device is manufactured by ANALYTICON BIOTECHNOLOGIES AG. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BRIDGE TWO.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ANALYTICON BIOTECHNOLOGIES AG.Country of Origin
Germany
Authorized Representative
PT. BRIDGE TWOAR Address
Petojo Melintang No. 17 Kel. Petojo Selatan, Kec. Gambir Jakarta Pusat
Registration Date
May 22, 2019
Expiry Date
Feb 04, 2024
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
H3/5-Hypoclean
H3-Check Complete
H3-Compact 500
H3-Compact 100
BIOLYZER FLUITEST GPT ALT
HEMOLYZER-5-Lyser
BIOLYZER TURBITEX CRP Latex
BIOLYZER FLUITEST GLU HK
BIOLYZER CONTROPATH Plus
HEMOLYZER 5 Control (L,N,H)
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.