IVD Department quantitative estradiol (E2) testing - Vietnam Registration 240001707/PCBB-HN
Access comprehensive regulatory information for IVD Department quantitative estradiol (E2) testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001707/PCBB-HN and manufactured by Fujirebio Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ARQON VIỆT NAM.
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Device Details
Registration Details
240001707/PCBB-HN
000.00.19.H26-240613-0004
Theo theo phụ lục
Theo phụ lục
Technical Details
1. Lumipulse G E2-III Immunoreaction Cartridges: For in vitro diagnostic use with LUMIPULSE G or serum. The E2 measurement can be used to assess ovarian function, monitor infertility treatment, and determine the time of ovulation in in vitro fertilization. This product is intended for professional use only. 2. Lumipulse G E2-III Calibrators: For in vitro diagnostic use in the calibration of the LUMIPULSE G System to quantify estradiol (E2) in serum or plasma. This product is intended for professional use only. 3. Lumipulse G Specimen Diluent 2: For in vitro diagnostic use: This product is a special reagent to dilute specimens in the Lumipulse G E2-III. This product is intended for professional use only.
Dates and Status
Jul 15, 2024