Standardization of the Quantitative Test for Acetaminophen, Carbamazepine, Digoxin, Phenobarbital, and Phenytoin
- Analysis ID
- 240001265/PCBB-HN
- Submission ID
- 000.00.19.H26-240521-0040
- Product Type
- VITROS Chemistry Products Calibrator Kit 9
- Product Code
- 8568040
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Product Owner
- Ortho-Clinical Diagnostics, Inc.
- Authorized Representative
- CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM
- Intended Use
- Used in in vitro diagnostic to calibrate the VITROS 250/350/5,1 FS/4600/ XT 3400 biochemical testing system and the VITROS 5600/ XT 7600 integrated system when quantifying ACET, CRBM, DGXN, PHBR and PHYT.
- Registration Date
- May 28, 2024
Access comprehensive regulatory information for Standardization of the Quantitative Test for Acetaminophen, Carbamazepine, Digoxin, Phenobarbital, and Phenytoin 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 240001265/PCBB-HN and manufactured by Ortho-Clinical Diagnostics, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.
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