Singapore HSA registration DE0507187
ACON Laboratories Mission® UTI Urinary Tract Infection Test Strips
Singapore·CLASS B IVD·ACON Laboratories, Inc.·Registered August 22, 2022Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0507187
- Registration Date
- August 22, 2022
- Retention Due Date
- August 21, 2025
Product description
The UTI Urinary Tract Infection Test Strips are for the detection of Leukocytes (LEU) and Nitrite (NIT) in human urine. It is used as an aid in the screening of urinary tract infection (UTI), and are intended for self-testing.
Product Owner
- Short Name
- ACON Laboratories, Inc.
- Address
- 5850 Oberlin Drive, #340, San Diego CA 92121, San Diego, California, UNITED STATES
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)
- UTI Urinary Tract Infection Test Strips Mission UTI Urinary Tract Infection Test Strips
- Model Identifier(s)
- 682607610037 682607610044
About this record
Access comprehensive regulatory information for ACON Laboratories Mission® UTI Urinary Tract Infection Test Strips in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0507187 and owned by ACON Laboratories, Inc.. The device was registered on August 22, 2022.
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 B IVD