Cortisol Quantitative Testing Drug
- Analysis ID
- 240002054/PCBB-HN
- Submission ID
- 000.00.19.H26-240812-0010
- Product Type
- Cortisol Rapid Quantitative Test
- Product Code
- W250
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- Product Owner
- Guangzhou Wondfo Biotech Co., Ltd.
- Authorized Representative
- CÔNG TY TNHH AVANTA DIAGNOSTICS
- Intended Use
- Finecare™ Cortisol Rapid Quantitative Test is a fluorescent immunoassay test used in conjunction with the Finecare™ FIA Fluorescent Immunoassay Machine (Models: FS-112, FS-113, FS-114, FS-205) to measure the quantitative concentration of Cortisol in whole blood, serum, and plasma samples from humans. The test is used to support the screening of adrenal dysfunction disorders and to evaluate the effectiveness of treatment. It is intended for professional in-vitro diagnostic use only.
- Registration Date
- Aug 15, 2024
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Access comprehensive regulatory information for Cortisol Quantitative Testing Drug 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 240002054/PCBB-HN and manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.
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