Vietnam MOH registration 220002689/PCBB-BYT

Quantitative PTH (1-84) Test Kit

VN: Bộ xét nghiệm định lượng PTH (1‑84)

Vietnam·Risk Class TTBYT Loại B·VIDAS PTH ( 1- 84 )·BIOMERIEUX SA·Registered Jul 14, 2022

Registration details

Analysis ID: 220002689/PCBB-BYT
Submission ID: 000.00.04.G18-220714-0019
Product Type: VIDAS PTH ( 1- 84 )
Product Code: 422010

Company information

Manufacturer: BIOMERIEUX SA
Manufacturer Country: 69280 Marcy L'Etoile

Technical details

Intended Use: VIDAS® PTH (1-84) (PTH) is an automated quantitative third-generation assay in the VIDAS® range, used to quantify the biological activity of PTH (1-84) of the parathyroid hormone in human serum or plasma by the ELFA (Enzyme Linked Fluorescent Assay) technique. It is used in conjunction with other laboratory and clinical assays to be used as follows: •As a diagnostic aid in hyperparathyroidism or hypoparathyroidism. •As a diagnostic aid to monitor calcium homeostasis in patients with chronic kidney disease..

Dates and status

Registration Date: Jul 14, 2022

About this record

Access comprehensive regulatory information for Quantitative PTH (1-84) Test Kit 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 220002689/PCBB-BYT and manufactured by BIOMERIEUX SA.

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