Singapore HSA registration DE0506284
Acon Biotech (Hangzhou) Flowflex SARS CoV 2 Antigen Rapid Test
Singapore·CLASS D·ACON BIOTECH (HANGZHOU) CO., LTD·Registered October 12, 2021Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0506284
- Registration Date
- October 12, 2021
- Retention Due Date
- October 11, 2025
Product description
The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. The SARS-CoV-2 Antigen Rapid Test cannot be used to test specimens from asymptomatic individuals. The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. The SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. SARS-CoV-2 Antigen Rapid Test is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.
Product Owner
- Short Name
- ACON BIOTECH (HANGZHOU) CO., LTD
- Address
- #210 ZHENZHONG ROAD, WEST LAKE DISTRICT, HANGZHOU P.R. CHINA 310030, 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)
- Nasopharyngeal Swab Nasal Swab Flowflex(TM) SARS-CoV-2 Antigen Rapid Test
- Model Identifier(s)
- CF 150-P 2 C CF 150-P 3 B L031-11815
About this record
Access comprehensive regulatory information for Acon Biotech (Hangzhou) Flowflex SARS CoV 2 Antigen Rapid Test in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506284 and owned by ACON BIOTECH (HANGZHOU) CO., LTD. The device was registered on October 12, 2021.
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