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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.

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240001395/PCBB-HCM
Registration Details
Vietnam MOH Registration: 240001395/PCBB-HCM
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Device Details

IVD Toxic Compound Cluster
VN: Cụm IVD Độc chất học
Risk Class TTBYT Loại B

Registration Details

240001395/PCBB-HCM

000.00.19.H29-240626-0002

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Acro Biotech, Inc.

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