WARM™ (Warm Autoantibody Removal Medium) - Indonesia BPOM Medical Device Registration
WARM™ (Warm Autoantibody Removal Medium) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209515083. 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
Oct 04, 2023
Expiry Date
Jul 14, 2028
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Stabilized enzyme solution.
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
CAPTURE-R Ready Screen Pooled Cells
IMMUCOR Anti-Kpa
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