Vietnam MOH registration 230000310/PCBB-BYT

α-methylacyl-CoA racemase (p504s) Qualitative Test Reagent

VN: Thuốc thử xét nghiệm định tính α-methylacyl-CoA racemase (p504s)

Vietnam·Risk Class TTBYT Loại B·anti-p504s (SP116) Rabbit Monoclonal Primary Antibody·Ventana Medical Systems, Inc.·Registered Jul 21, 2023

Registration details

Analysis ID: 230000310/PCBB-BYT
Submission ID: 000.00.04.G18-230721-0002
Product Type: anti-p504s (SP116) Rabbit Monoclonal Primary Antibody
Product Code: 08035130001

Company information

Manufacturer: Ventana Medical Systems, Inc.
Manufacturer Country: Tucson AZ 85755

Technical details

Intended Use: Anti- p504s (SP116) Rabbit Monoclonal Primary Antibody is used in the laboratory to detect α-methylacyl-CoA racemase (AMACR, also known as p504s) by immunohistochemistry on formalin-fixed, paraffin-embedded tissue sections observed under the light microscope. This product must be interpreted by a qualified pathologist in conjunction with histology, relevant clinical information, and appropriate control material. This antibody is intended for in vitro diagnostic use (IVD).

Dates and status

Registration Date: Jul 21, 2023

About this record

Access comprehensive regulatory information for α-methylacyl-CoA racemase (p504s) Qualitative Test Reagent 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 230000310/PCBB-BYT and manufactured by Ventana Medical Systems, Inc..

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