CORQC Extend Standard - Indonesia BPOM Medical Device Registration
CORQC Extend Standard is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209320605. The device is manufactured by IMMUCOR, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
IMMUCOR, INC.Country of Origin
United States
Authorized Representative
PT. ENSEVAL MEDIKA PRIMAAR Address
JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG
Registration Date
Aug 31, 2023
Expiry Date
Jul 14, 2028
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Quality control kit for blood banking reagents.
Invitro Diagnostics
IMMUCOR Anti - s (Monoclonal) Gamma-clone
CAPTURE-P Control Set
PANOCELL Ficin-Treated
PANOCELL
IMMUCOR Specimen Diluent
IMMUCOR Anti-Jka (Monoclonal) Gamma-clone
CAPTURE-R Ready Indicator Red Cells
WARM™ (Warm Autoantibody Removal Medium)
CAPTURE-R Ready Screen Pooled Cells
IMMUCOR Anti-Kpa
MEDRAD Salient Contrast Injector Wireless
PLEXUS MANUFACTURING SDN. BHD. (HILLSIDE)
MEDRAD Salient Contrast Injector Non-Wireless
PLEXUS MANUFACTURING SDN. BHD. (HILLSIDE)
HOKAPI™ CUVETTE
SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD
DENSICHECK Plus Instrument for VITEK 2 System and Accessories
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VITEK MS System and Accessories
KRATOS ANALYTICAL LTD.
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AIDIAN
BIOMERIEUX Uriline
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BacT/ALERT VIRTUO Microbial Detection System and Accessories
BIOMERIEUX INC. (MISSOURI)
Bact/Alert 3D 240
BIOMERIEUX INC. (Missouri)
FILMARRAY Torch and accessories
BIOFIRE DIAGNOSTICS, LLC