Vietnam MOH registration 240001395/PCBB-HCM

IVD Toxic Compound Cluster

VN: Cụm IVD Độc chất học

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Acro Biotech, Inc.·Registered Jul 08, 2024

Registration details

Analysis ID: 240001395/PCBB-HCM
Submission ID: 000.00.19.H29-240626-0002
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Acro Biotech, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Acro Biotech, Inc.
Authorized Representative: CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA

Technical details

Intended Use: 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

Registration Date: Jul 08, 2024

About this record

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.

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