Singapore HSA registration DE0017952
Acon Insight® Urinalysis Reagent Strips
Singapore·CLASS B IVD·ACON Laboratories, Inc.·Registered March 17, 2016Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0017952
- Registration Date
- March 17, 2016
- Retention Due Date
- March 16, 2026
Product description
The Urinalysis Reagent Strips (Urine) are firm plastic strips onto which several separate reagent areas are affixed. The test is for the qualitative and semi-quantitative detection of one or more of the following analytes in urine: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Insight® Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations. Refer to kit box label for the specific analyte(s) listed, and compare to the appropriate analyte(s) and colour blocks on the colour chart for results. The Urinalysis Reagent Strips (Urine) can be read visually and on the Insight® Urine Analysers, and are intended for professional use only.
Product Owner
- Short Name
- ACON Laboratories, Inc.
- Address
- 10125 Mesa Rim Road, San Diego, CA 92121, UNITED STATES
Registrant
- Name
- JOYSON PTE. LTD.
- Address
- 3 UPPER ALJUNIED LINK, #06-03, SINGAPORE 367902
Importer
- Name
- JOYSON PTE. LTD.
- Address
- 3 UPPER ALJUNIED LINK, #06-03, SINGAPORE 367902
Model information
- Model Name(s)
- Insight® Urinalysis Reagent Strips 1B Insight® Urinalysis Reagent Strips 1BE Insight® Urinalysis Reagent Strips 1G Insight® Urinalysis Reagent Strips 1GE Insight® Urinalysis Reagent Strips 1K Insight® Urinalysis Reagent Strips 1KE Insight® Urinalysis Reagent Strips 1P Insight® Urinalysis Reagent Strips 1PE Insight® Urinalysis Reagent Strips 1R Insight® Urinalysis Reagent Strips 1RE Insight® Urinalysis Reagent Strips 2B Insight® Urinalysis Reagent Strips 2BE Insight® Urinalysis Reagent Strips 2G Insight® Urinalysis Reagent Strips 2GE Insight® Urinalysis Reagent Strips 2K Insight® Urinalysis Reagent Strips 2KE Insight® Urinalysis Reagent Strips 2N Insight® Urinalysis Reagent Strips 2NE Insight® Urinalysis Reagent Strips 2S Insight® Urinalysis Reagent Strips 2SE Insight® Urinalysis Reagent Strips 2U Insight® Urinalysis Reagent Strips 2UE Insight® Urinalysis Reagent Strips 3G Insight® Urinalysis Reagent Strips 3GE Insight® Urinalysis Reagent Strips 3K Insight® Urinalysis Reagent Strips 3KE Insight® Urinalysis Reagent Strips 3N Insight® Urinalysis Reagent Strips 3NE Insight® Urinalysis Reagent Strips 3P Insight® Urinalysis Reagent Strips 3PE Insight® Urinalysis Reagent Strips 4B Insight® Urinalysis Reagent Strips 4BE Insight® Urinalysis Reagent Strips 4G Insight® Urinalysis Reagent Strips 4GE Insight® Urinalysis Reagent Strips 4K Insight® Urinalysis Reagent Strips 4KE Insight® Urinalysis Reagent Strips 4N Insight® Urinalysis Reagent Strips 4NE Insight® Urinalysis Reagent Strips 4P Insight® Urinalysis Reagent Strips 4PE Insight® Urinalysis Reagent Strips 4S Insight® Urinalysis Reagent Strips 4SE Insight® Urinalysis Reagent Strips 5B Insight® Urinalysis Reagent Strips 5BE Insight® Urinalysis Reagent Strips 5N Insight® Urinalysis Reagent Strips 5NE Insight® Urinalysis Reagent Strips 5S Insight® Urinalysis Reagent Strips 5SE Insight® Urinalysis Reagent Strips 5U Insight® Urinalysis Reagent Strips 5UE Insight® Urinalysis Reagent Strips 6N Insight® Urinalysis Reagent Strips 6NE Insight® Urinalysis Reagent Strips 6U Insight® Urinalysis Reagent Strips 6UE Insight® Urinalysis Reagent Strips 7N Insight® Urinalysis Reagent Strips 8N Insight® Urinalysis Reagent Strips 8S Insight® Urinalysis Reagent Strips 8U Insight® Urinalysis Reagent Strips 9U Insight® Urinalysis Reagent Strips 10A Insight® Urinalysis Reagent Strips 10U Insight® Urinalysis Reagent Strips 11A Insight® U120 Urine Analyzer Insight® U120 Urine Analyzer with Barcode Reader Insight® Printer Paper Rolls Insight® U500 Urine Analyzer Insight® U500 Urine Analyzer with Barcode Reader Insight® Barcode Reader Insight® U120/U500 Data Transfer Kit
- Model Identifier(s)
- U031-015-B U031-015-BE U031-015-G U031-015-GE U031-015-K U031-015-KE U031-015-P U031-015-PE U031-015-R U031-015-RE U031-025-B U031-025-BE U031-025-G U031-025-GE U031-025-K U031-025-KE U031-025-N U031-025-NE U031-025-S U031-025-SE U031-025-U U031-025-UE U031-035-G U031-035-GE U031-035-K U031-035-KE U031-035-N U031-035-NE U031-035-P U031-035-PE U031-045-B U031-045-BE U031-045-G U031-045-GE U031-045-K U031-045-KE U031-045-N U031-045-NE U031-045-P U031-045-PE U031-045-S U031-045-SE U031-055-B U031-055-BE U031-055-N U031-055-NE U031-055-S U031-055-SE U031-055-U U031-055-UE U031-065-N U031-065-NE U031-065-U U031-065-UE U031-075-N U031-085-N U031-085-S U031-085-U U031-095 U031-105-A U031-105-U U031-115 U111-105 U111-115 U121-105 U211-105 U211-115 U221-115 U221-135
About this record
Access comprehensive regulatory information for Acon Insight® Urinalysis Reagent 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 DE0017952 and owned by ACON Laboratories, Inc.. The device was registered on March 17, 2016.
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.
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