BIO-RAD Access HIV combo V2 QC plus - Indonesia BPOM Medical Device Registration

BIO-RAD Access HIV combo V2 QC plus is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323973. The device is manufactured by BIO-RAD from France, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DHH TRADING INDONESIA.

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.

Free Database

Powered by Pure Global AI

BPOM Registered

Risk Class Kelas Resiko : B

BIO-RAD Access HIV combo V2 QC plus

Analysis ID: AKL 20101323973

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

Country of Origin

France

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

Sep 29, 2023

Expiry Date

Feb 10, 2026

Product Type

Clinical Chemistry Test System

Quality control material (assayed and unassayed) (cair)

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Other Products from BIO-RAD

Products from the same manufacturer (10 products)

Geenius HIV 1/2 Confirmatory Assay

Kelas Resiko : D

Access HIV combo V2

Kelas Resiko : D

Access HIV combo V2 Calibrators

Kelas Resiko : B

Access HIV combo V2 QC

Kelas Resiko : B

MONOLISA HBs Ag ULTRA

Kelas Resiko : D

MONOLISA HCV Ag-Ab ULTRA V2

Kelas Resiko : D

GEENIUS™ Reader and Accessories

Kelas Resiko : A

Geenius™ HCV Supplemental Controls

Kelas Resiko : B

BIO-RAD IH-1000 and Accessories

Kelas Resiko : C

Geenius™ HIV 1/2 Confirmatory Controls

Kelas Resiko : B

Other Products from PT. DHH TRADING INDONESIA

Products with the same authorized representative (10 products)

BECKMAN COULTER Access Thyroglobulin Antibody - II

BECKMAN COULTER ,INC

Kelas Resiko : B

BECKMAN COULTER Access Thyroglobulin

BECKMAN COULTER, INC (CHASKA)

Kelas Resiko : B

BECKMAN COULTER Access Progesterone II

BECKMAN COULTER ,INC

Kelas Resiko : B

iQ Precision Kit

BECKMAN COULTER INC.

Kelas Resiko : B

iQ Body Fluids Lysing Reagent

BECKMAN COULTER INC.

Kelas Resiko : B

iChem VELOCITY Urine Chemistry Strips

BECKMAN COULTER IRELAND, INC.

Kelas Resiko : C

iQ 200 Sprint Plus Analyzer (2008 Version) (Int'l)

BECKMAN COULTER INC.

Kelas Resiko : B

iQ Lamina™

BECKMAN COULTER, INC.

Kelas Resiko : A

iChem® VELOCITY™ CalChek Kit

BECKMAN COULTER, INC.

Kelas Resiko : A

iQ Control/Focus Set

BECKMAN COULTER INC.

Kelas Resiko : B