Vietnam MOH registration 240002740/PCBB-HN

IVD Department Quantitative Testosterone Test

VN: Bộ IVD xét nghiệm định lượng Testosterone

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Fujirebio Inc.·Registered Oct 14, 2024

Registration details

Analysis ID: 240002740/PCBB-HN
Submission ID: 000.00.19.H26-240725-0005
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Fujirebio Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Fujirebio Inc.
Authorized Representative: CÔNG TY TNHH ARQON VIỆT NAM

Technical details

Intended Use: 1. Lumipulse G Testosterone Immunoreaction Cartridges: For in vitro diagnosis using the LUMIPULSE G System to quantify testosterone in blood plasma or serum. This product is intended for professional use only. 2. Lumipulse G Testosterone Calibrators: For in vitro diagnosis and calibration of the LUMIPULSE G System to quantify testosterone in blood plasma or serum. This product is intended for professional use only. 3. Lumipulse G Specimen Diluent 3: For in vitro diagnosis: This product is a special reagent to dilute specimens in the Lumipulse G Testosterone. This product is intended for professional use only.

Dates and status

Registration Date: Oct 14, 2024

About this record

Access comprehensive regulatory information for IVD Department Quantitative Testosterone Test in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002740/PCBB-HN and manufactured by Fujirebio Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ARQON VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.