Singapore HSA registration DE0507925

Hangzhou AllTest Biotech Alltest Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma)

Singapore flagSingapore·CLASS C IVD·HANGZHOU ALLTEST BIOTECH CO.,LTD·Registered March 22, 2023
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0507925
Registration Date
March 22, 2023
Retention Due Date
March 21, 2026
Product description
The Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis.
Product Owner
Short Name
HANGZHOU ALLTEST BIOTECH CO.,LTD
Address
#550, Yinhai Street, Hangzhou Economic & Technological, Development Area, Hangzhou, 310018 P.R. China, Hangzhou, CHINA
Registrant
Address
25 BUKIT BATOK CRESCENT, THE ELITIST, #09-13, SINGAPORE 658066
Importer
Address
25 BUKIT BATOK CRESCENT, THE ELITIST, #09-13, SINGAPORE 658066 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674 400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model information
Model Name(s)
AllTest Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma)
Model Identifier(s)
ISY-402
About this record

Access comprehensive regulatory information for Hangzhou AllTest Biotech Alltest Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma) in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0507925 and owned by HANGZHOU ALLTEST BIOTECH CO.,LTD. The device was registered on March 22, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD