Singapore HSA registration DE0507065
Acon Laboratories Distinct Early Detection Pregnancy Test
Singapore·CLASS B IVD·ACON Laboratories, Inc.·Registered July 07, 2022Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0507065
- Registration Date
- July 07, 2022
- Retention Due Date
- July 06, 2025
Product description
The Distinct Early Detection Pregnancy Test is an aid for the early detection of pregnancy intended for home use. The device is a chromatographic immunoassay that performs qualitative detection of human chorionic gonadotropin (hCG) in urine. This test can help determine pregnancy as early as 6 days before the day of the missed period (5 days before the day of the expected period).
Product Owner
- Short Name
- ACON Laboratories, Inc.
- Address
- 5850 Oberlin Drive, #340, San Diego, CA 92121, UNITED STATES
Registrant
- Address
- 1 SHENTON WAY, ONE SHENTON, #35-05, SINGAPORE 068803
Importer
- Address
- 1 SHENTON WAY, ONE SHENTON, #35-05, SINGAPORE 068803
Model information
- Model Name(s)
- Distinct Early Detection Pregnancy Test Midstream (2 tests/kit, 3 tests/kit)
- Model Identifier(s)
- L031-20192
About this record
Access comprehensive regulatory information for Acon Laboratories Distinct Early Detection Pregnancy Test 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 DE0507065 and owned by ACON Laboratories, Inc.. The device was registered on July 07, 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