IMMUCOR Gamma Lewis Blood Group Substance - Indonesia BPOM Medical Device Registration
IMMUCOR Gamma Lewis Blood Group Substance is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10209516408. The device is manufactured by IMMUCOR INC. from United States, and is classified as Risk Class Kelas Resiko : C. 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
Aug 28, 2023
Expiry Date
Jul 14, 2028
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Blood group substances of nonhuman origin for in vitro diagnostic use.
Invitro Diagnostics
CAPTURE-R READY SCREEN (3)
IMMUCOR Anti-IgG,-C3d; Polyspecific (Murine Monoclonal) (Green or Uncolored) Gamma Clone
IMMUCOR Anti-S (Monoclonal) Gamma-clone
IMMUCOR Gamma EGA Kit
RESt (Rabbit Erythrocyte Stroma for Adsorption of Cold Agglutinins Anti-I , Anti-H or Anti-IH)
IMMUCOR Weak D Cells
IMMUCOR Complement Control Cells
Gamma ELU-KIT II
IMMUCOR Reagent Red Blood Cells CAPTURE-R Ready-Screen (I and II)
IMMUCOR Anti-H Lectin
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