ALINITY i DHEA-S Controls - Indonesia BPOM Medical Device Registration
ALINITY i DHEA-S Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101913671. The device is manufactured by BIOKIT, S.A from Spain, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BIOKIT, S.ACountry of Origin
Spain
Authorized Representative
ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Oct 27, 2022
Expiry Date
Jun 01, 2027
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
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ALINITY c ASO-RF Control II Kit
Lp(a) Calibrators
Alinity c RF Reagent Kit
ALINITY c ASO Standard
ALINITY c Lp(a) Calibrators
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