Singapore HSA registration DE0507846
Hangzhou Alltest Biotech ALLTEST SARS-CoV-2 Antigen Rapid Test (Nasal Swab)
Singapore·CLASS D IVD·HANGZHOU ALLTEST BIOTECH CO.,LTD·Registered March 02, 2023Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0507846
- Registration Date
- March 02, 2023
- Retention Due Date
- March 01, 2026
Product description
The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in nasal swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.
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
- Name
- ALCOTECH PTE LTD
- Address
- 25 BUKIT BATOK CRESCENT, THE ELITIST, #09-13, SINGAPORE 658066
Importer
- Name
- ALCOTECH PTE LTD
- Address
- 25 BUKIT BATOK CRESCENT, THE ELITIST, #09-13, SINGAPORE 658066
Model information
- Model Name(s)
- ALLTEST SARS-CoV-2 Antigen Rapid Test (Nasal Swab)
- Model Identifier(s)
- INCP-502-N
About this record
Access comprehensive regulatory information for Hangzhou Alltest Biotech ALLTEST SARS-CoV-2 Antigen Rapid Test (Nasal Swab) in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0507846 and owned by HANGZHOU ALLTEST BIOTECH CO.,LTD. The device was registered on March 02, 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 D IVD