Vietnam MOH registration 240002184/PCBB-HN

Syphilis Antibody Qualitative Test Kit

VN: Que thử/ Khay thử xét nghiệm định tính kháng thể kháng Syphilis

Vietnam·Risk Class TBYT Loại B·Syphilis Ab Rapid Test Kit·VİTROSENS BİYOTEKNOLOJİ ANONİM ŞİRKETİ·Registered Aug 27, 2024

Registration details

Analysis ID: 240002184/PCBB-HN
Submission ID: 000.00.19.H26-240814-0036
Product Type: Syphilis Ab Rapid Test Kit
Product Code: VMD04

Company information

Manufacturer: VİTROSENS BİYOTEKNOLOJİ ANONİM ŞİRKETİ
Product Owner: VİTROSENS BİYOTEKNOLOJİ ANONİM ŞİRKETİ
Authorized Representative: CÔNG TY CỔ PHẦN TẬP ĐOÀN TH MEDICAL

Technical details

Intended Use: Syphilis Ab Rapid Test Kit is used to qualitatively determine the presence of treponema pallidum antibodies in human serum /plasma /whole blood. This test is a screening test and all positive results must be confirmed by an alternate test such as Western blot. It is intended for use as a health screening test.

Dates and status

Registration Date: Aug 27, 2024

About this record

Access comprehensive regulatory information for Syphilis Antibody Qualitative Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002184/PCBB-HN and manufactured by VİTROSENS BİYOTEKNOLOJİ ANONİM ŞİRKETİ. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN TẬP ĐOÀN TH MEDICAL.

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