Vietnam MOH registration 240000026/PCBMT-BYT
Vietnam·IMMUNOASSAY PREMIUM PLUS-TRI-LEVEL (IA PREMIUM PLUS 1, 2 AND 3)·Randox Laboratories Limited·Registered Feb 05, 2024Registration details
- Analysis ID
- 240000026/PCBMT-BYT
- Submission ID
- 000.00.04.G18-240205-0006
- Product Type
- IMMUNOASSAY PREMIUM PLUS-TRI-LEVEL (IA PREMIUM PLUS 1, 2 AND 3)
Company information
- Manufacturer
- Randox Laboratories Limited
- Manufacturer Country
- Northern Ireland
- Authorized Representative
- CÔNG TY CỔ PHẦN GIẢI PHÁP Y TẾ GS
Technical details
- Intended Use
- Quantitative Assay Control Material 54 Immunological Assay Control Material is designed for use in in vitro diagnostic, the quality control material that has been tested to monitor the accuracy and reproducibility of 54 Analytical Parameters including: 17-OH-Progesterone, 1-25- (OH)2-Vitamin D, 25-OH-Vitamin D, α-Fetoprotein (AFP), ACTH+, Aldosterone+, Amikacin, Androstenedione, β-2-Microglobulin, C-peptide, CA 15-3, CA 19-9, CA 125, Carbamazepine, CEA, Cortisol, DHEA-Sulphate, Digoxin, Estriol, Ethosuximide, Feritin, Folate, FSH, Gentamicin, Growth Hormone (GH), hCG, Immunoglobulin E (IgE), Insulin, Luteinising Hormone (LH), Oestradiol, Paracetamol, Phenobarbitone, Phenytoin, Primidone, Progesterone, Prolactin, PSA (Free), PSA (Total), Salicylate, Sex Hormone Binding Globulin (SHBG), T Uptake, T3 (Free) T3 (Total), T4 (Free), T4 (Total), Testosterone, Testosterone (Free), Theophyline, Thyroglobulin, Tobramycin, TSH, Valproic Acid, Vancomycin, Vitamin B12. For Professional Use Only
- Concentration/Content
- Immunoassay Premium Plus Control Level 1 < 0.001 g/L; Immunoassay Premium Plus Control Level 2: 0.001 - 0.01 g/L; Immunoassay Premium Plus Control Level 3: 0.001 - 0.01 g/L
Dates and status
- Registration Date
- Feb 05, 2024
About this record
Access comprehensive regulatory information for in Vietnam's medical device market through Pure Global AI's free database. is registered under number 240000026/PCBMT-BYT and manufactured by Randox Laboratories Limited. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN GIẢI PHÁP Y TẾ GS.
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