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ACON Laboratories Distinct Ovulation Rapid test - HSA Registration DE0507048

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.

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CLASS B IVD
DE0507048
ACON Laboratories Distinct Ovulation Rapid test
HSA Registration Number: DE0507048
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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.

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 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