- Vietnam Registration 240000026/PCBMT-BYT
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 CรNG TY Cแป PHแบฆN GIแบขI PHรP Y Tแบพ GS.
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Device Details
Registration Details
240000026/PCBMT-BYT
000.00.04.G18-240205-0006
IMMUNOASSAY PREMIUM PLUS-TRI-LEVEL (IA PREMIUM PLUS 1, 2 AND 3)
Technical Details
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, ฮฑ-Fetoprotein (AFP), ACTH+, Aldosterone+, Amikacin, Androstenedione, ฮฒ-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
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
Feb 05, 2024