IVD Toxic Compound Cluster - Vietnam Registration 240001395/PCBB-HCM
Access comprehensive regulatory information for IVD Toxic Compound Cluster 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 240001395/PCBB-HCM and manufactured by Acro Biotech, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA.
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.
Device Details
Registration Details
240001395/PCBB-HCM
000.00.19.H29-240626-0002
Theo theo phụ lục
Theo phụ lục
Technical Details
1. AMP Rapid Test Dipstick (Urine) is an immunoassay chromatographic rapid test to detect Amphetamine in human urine at a concentration limit of 1.000 ng/mL. The test will detect other related compounds, please refer to the Analytical Specificity Table in this manual. This test provides only a preliminary qualitative analysis result. A more specific chemical method must be used to obtain the confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical evaluation and professional judgment must be considered for any drug with a positive abuse test result, especially when a preliminary positive result is used. 2. BAR Rapid Test Dipstick (Urine) is an immunoassay chromatographic flow-through test to detect Barbiturates in urine at a concentration limit of 300 ng/mL. The test will detect other related compounds, please refer to the Analytical Specificity Table in this manual. This test provides only a preliminary qualitative analysis result. A more specific chemical method must be used to obtain the confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical evaluation and professional judgment must be considered for any drug with a positive abuse test result, especially when a preliminary positive result is used. 3. BZO Rapid Test Dipstick (Urine) is an immunoassay chromatographic rapid test to detect Oxazepam (the main metabol
Dates and Status
Jul 08, 2024

