Singapore HSA registration DE0017953

Acon Insight® Expert Urinalysis Reagent Strips

Singapore flagSingapore·CLASS B IVD·ACON Laboratories, Inc.·Registered March 17, 2016
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration information
Registration Number
DE0017953
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: Specific Gravity, pH, Leukocytes, Nitrite, Protein, Glucose, Ketone Bodies, Urobilinogen, Bilirubin, Blood, and Ascorbic Acid. The Insight® Expert 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® Expert 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
Address
3 UPPER ALJUNIED LINK, #06-03, SINGAPORE 367902
Importer
Address
3 UPPER ALJUNIED LINK, #06-03, SINGAPORE 367902
Model information
Model Name(s)
Insight® Expert Urinalysis Reagent Strips 1G Insight® Expert Urinalysis Reagent Strips 1GE Insight® Expert Urinalysis Reagent Strips 2G Insight® Expert Urinalysis Reagent Strips 2GE Insight® Expert Urinalysis Reagent Strips 2K Insight® Expert Urinalysis Reagent Strips 2KE Insight® Expert Urinalysis Reagent Strips 3C Insight® Expert Urinalysis Reagent Strips 3CE Insight® Expert Urinalysis Reagent Strips 3T Insight® Expert Urinalysis Reagent Strips 3TE Insight® Expert Urinalysis Reagent Strips 4U Insight® Expert Urinalysis Reagent Strips 4UE Insight® Expert Urinalysis Reagent Strips 5K Insight® Expert Urinalysis Reagent Strips 5KE Insight® Expert Urinalysis Reagent Strips 9N Insight® Expert Urinalysis Reagent Strips 10S Insight® Expert Urinalysis Reagent Strips 11U Insight® Expert U120 Urine Analyzer Insight® Expert U120 Urine Analyzer with Barcode Reader Insight® Expert Printer Paper Rolls Insight® Expert U500 Urine Analyzer Insight® Expert U500 Urine Analyzer with Barcode Reader Insight® Expert Barcode Reader Insight® Expert U120/U500 Data Transfer Kit
Model Identifier(s)
U033-015-G U033-015-GE U033-025-G U033-025-GE U033-025-K U033-025-KE U033-035-C U033-035-CE U033-035-T U033-035-TE U033-045-U U033-045-UE U033-055-K U033-055-KE U033-095 U033-105 U033-115 U113-105 U113-115 U123-105 U213-105 U213-115 U223-115 U223-135
About this record

Access comprehensive regulatory information for Acon Insight® Expert 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 DE0017953 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD