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Innovacon SureStepTM Urine Test Drug Screen Cassette - HSA Registration DE0506971

Access comprehensive regulatory information for Innovacon SureStepTM Urine Test Drug Screen Cassette 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 DE0506971 and owned by Innovacon Inc. The device was registered on June 17, 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
DE0506971
Innovacon SureStepTM Urine Test Drug Screen Cassette
HSA Registration Number: DE0506971
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Product Description

A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine: Amphetamine, Cocaine, Marijuana (THC), Morphine, Phencyclidine, Benzodiazepines, Methadone, Opiate, Barbiturate, Methamphetamine, Methylenedioxy-methamphetamine, and Tricyclic Antidepressants.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical toxicology
Registration Information
Registration Number
DE0506971
Registration Date
June 17, 2022
Change Notification Approval Date
December 06, 2024
Retention Due Date
June 16, 2025
Product Owner
Short Name
Innovacon Inc
Address
9942 Mesa Rim Road,, San Diego, CA, CA 92121, UNITED STATES
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352 10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model Information
Model Name(s)
SureStepTM Urine Test Drug Screen Cassette SureStepTM Urine Test Drug Screen Cassette SureStepโ„ข Multi-Drug One Step Multi-Line ScreenTest Device (Urine) SureStepโ„ข Multi-Drug One Step Multi-Line ScreenTest Device (Urine) SureStepโ„ข Multi-Drug One Step Multi-Line Screen Test Device (Urine) SureStepโ„ข Multi-Drug One Step Multi-Line ScreenTest Device (Urine)
Model Identifier(s)
DOA-1105-031-a-ICBC03 DOA-1105-061-a DOA-155-161-a DOA-165-121-a DOA-165-131-a DOA-165-261-a