Positive control material for in situ hybridization to determine the integrity of DNA - Vietnam Registration 240000668/PCBB-HCM
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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Device Details
Registration Details
240000668/PCBB-HCM
000.00.19.H29-240318-0003
Alu Positive Control Probe
05278694001
Technical Details
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
Apr 01, 2024