Singapore HSA registration DE0507048
ACON Laboratories Distinct Ovulation Rapid test
Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0507048
- Registration Date
- July 05, 2022
- Retention Due Date
- July 04, 2025
Product description
The Ovulation Rapid Test Midstream and Cassette (Urine) are rapid chromatographic immunoassay for the qualitative detection of luteinizing hormone (LH) in urine to aid in the detection of ovulation.
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 LH Ovulation Rapid Test Cassette (Urine) Distinct Ovulation Rapid Test Midstream
- Model Identifier(s)
- L031-20232 L031-20242
About this record
Access comprehensive regulatory information for ACON Laboratories Distinct Ovulation Rapid 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 DE0507048 and owned by ACON Laboratories, Inc.. The device was registered on July 05, 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