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- Vietnam Registration 240000025/PCBMT-BYT

Access comprehensive regulatory information for in Vietnam's medical device market through Pure Global AI's free database. is registered under number 240000025/PCBMT-BYT and manufactured by Randox Laboratories Limited. The authorized representative in Vietnam is Cร”NG TY Cแป” PHแบฆN GIแบขI PHรP Y Tแบพ GS.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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240000025/PCBMT-BYT
Registration Details
Vietnam MOH Registration: 240000025/PCBMT-BYT
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Device Details

Registration Details

240000025/PCBMT-BYT

000.00.04.G18-240205-0005

IMMUNOASSAY PREMIUM PLUS-LEVEL 3 (IA PREMIUM PLUS 3)

Company Information

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

0.001 - 0.01 g/L

Dates and Status

Feb 05, 2024