Vietnam MOH registration 240000668/PCBB-HCM

Positive control material for in situ hybridization to determine the integrity of DNA

VN: Vật liệu kiểm soát dương tính xét nghiệm lai tại chỗ để xác định sự bảo toàn của DNA

Vietnam·Risk Class TTBYT Loại B·Alu Positive Control Probe·Ventana Medical Systems, Inc.·Registered Apr 01, 2024

Registration details

Analysis ID: 240000668/PCBB-HCM
Submission ID: 000.00.19.H29-240318-0003
Product Type: Alu Positive Control Probe
Product Code: 05278694001

Company information

Manufacturer: Ventana Medical Systems, Inc.
Product Owner: Ventana Medical Systems, Inc.
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: Alu Positive Control Probe is a mixture of fluorescently labeled oligonucleotide probes used in the laboratory as a positive control material (positive control sample) to determine the integrity of DNA in the process of sample collection and processing, in formalin-fixed paraffin-embedded tissue sections. This product must be interpreted by a pathologist with combined expertise in histology, relevant clinical information, and appropriate control material (positive control sample). This product is intended for in vitro diagnostic use (IVD).

Dates and status

Registration Date: Apr 01, 2024

About this record

Access comprehensive regulatory information for Positive control material for in situ hybridization to determine the integrity of DNA 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 240000668/PCBB-HCM and manufactured by Ventana Medical Systems, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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