Vietnam MOH registration 240002901/PCBB-HN

IVD Department quantitative testing of triiodothyronine (T3)

VN: Bộ IVD xét nghiệm định lượng triiodothyronine (T3)

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Fujirebio Inc.·Registered Oct 28, 2024

Registration details

Analysis ID: 240002901/PCBB-HN
Submission ID: 000.00.19.H26-241024-0014
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 T3 Immunoreaction Cartridges: For in vitro diagnosis using the LUMIPULSE G System to quantify triiodothyronine (T3) in serum or plasma. This product is intended for professional use only. 2. Lumipulse G T3 Calibrators: For in vitro diagnosis in the calibration of the LUMIPULSE G System to quantify triiodothyronine (T3) in serum or plasma. This product is intended for professional use only.

Dates and status

Registration Date: Oct 28, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative testing of triiodothyronine (T3) 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 240002901/PCBB-HN and manufactured by Fujirebio Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ARQON VIỆT NAM.

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