IVD Department Quantitative HbA1c Testing
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·I.S.E. S.r.l·Registered Aug 29, 2024- Analysis ID
- 240002229/PCBB-HN
- Submission ID
- 000.00.19.H26-240827-0010
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- I.S.E. S.r.l
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- I.S.E. S.r.l
- Authorized Representative
- CÔNG TY TNHH THƯƠNG MẠI KỸ THUẬT TPCOM
- Intended Use
- -HbA1c: to determine the in vitro concentration of Hemoglobin A1c (HbA1c) in human serum or plasma. -HbA1c Calibrator: used to calibrate the quantitative test for Hemoglobin A1c (HbA1c) in human serum or plasma. -HbA1c Control High/ HbA1c Control low: used to control the quality of the quantitative test for Hemoglobin A1c (HbA1c) in human serum or plasma.
- Registration Date
- Aug 29, 2024
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Access comprehensive regulatory information for IVD Department Quantitative HbA1c Testing 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 240002229/PCBB-HN and manufactured by I.S.E. S.r.l. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI KỸ THUẬT TPCOM.
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