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DIAZYME Procalcitonin Assay - Indonesia BPOM Medical Device Registration

DIAZYME Procalcitonin Assay is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303320967. The device is manufactured by DIAZYME LABORATORIES INC from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DHH TRADING INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
DIAZYME Procalcitonin Assay
Analysis ID: AKL 20303320967

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. DHH TRADING INDONESIA

AR Address

Gedung World Trade Center 3, Lt. 20, Jl. Jend. Sudirman Kav. 29-31, Kel. Karet, Kec. Setiabudi, Jakarta Selatan, DKI Jakarta

Registration Date

Feb 09, 2023

Expiry Date

Feb 10, 2026

Product Type

Serological Reagents

Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis

Invitro Diagnostics

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