IMMUCOR Specimen Diluent - Indonesia BPOM Medical Device Registration
IMMUCOR Specimen Diluent is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208913051. 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.
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
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
Oct 14, 2023
Expiry Date
Jul 14, 2028
Product Type
Hematological Reagents
Blood cell diluents
Invitro Diagnostics
IMMUCOR Anti - s (Monoclonal) Gamma-clone
CAPTURE-P Control Set
PANOCELL Ficin-Treated
PANOCELL
IMMUCOR Anti-Jka (Monoclonal) Gamma-clone
WARM™ (Warm Autoantibody Removal Medium)
CAPTURE-R Ready Indicator Red Cells
CAPTURE-R Ready Screen Pooled Cells
IMMUCOR Anti-Kpa
REFERENCELLS - 2 (Group A1 and B)
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
BIOMERIEUX INC.
VITEK MS System and Accessories
KRATOS ANALYTICAL LTD.
BIOMERIEUX Mycoline
AIDIAN
BIOMERIEUX Uriline
AIDIAN
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