Singapore HSA registration DE0507671
Hologic Aptima® SARS-CoV-2 Assay
Singapore·CLASS D IVD·Hologic, Inc.·Registered January 09, 2023Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0507671
- Registration Date
- January 09, 2023
- Change Notification Approval Date
- January 03, 2025
- Retention Due Date
- January 08, 2026
Product description
The Aptima™ SARS‐CoV‐2 assay is a nucleic acid amplification test for the qualitative detection of RNA from SARS‐CoV‐2 isolated from nasopharyngeal (NP), nasal, mid‐turbinate and oropharyngeal (OP) swab specimens from individuals meeting COVID‐19 clinical and/or epidemiological criteria. This test is also for the qualitative detection of nucleic acid from the SARS‐CoV‐2 in pooled samples containing up to 5 individual upper respiratory swab specimens. Negative results from pooled testing should not be treated as definitive. Specimens included in pools with a positive or invalid result must be tested individually prior to reporting a result. The Aptima SARS-CoV-2 assay on the Panther™ and Panther Fusion™ system is intended for use by clinical laboratory personnel specifically instructed and trained in the operation of the Panther and Panther Fusion systems and in vitro diagnostic procedures.
Product Owner
- Name
- Hologic, Inc.
- Short Name
- Hologic, Inc.
- Address
- 10210 Genetic Center Drive, San Diego, California 92121, UNITED STATES
Registrant
- Address
- 36 ROBINSON ROAD, CITY HOUSE, #10-01-05, SINGAPORE 068877
Importer
- Address
- 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model information
- Model Name(s)
- Aptima® SARS CoV-2 Assay Aptima® SARS-CoV-2 Assay Controls Kit
- Model Identifier(s)
- PRD-06419 PRD-06420
About this record
Access comprehensive regulatory information for Hologic Aptima® SARS-CoV-2 Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0507671 and owned by Hologic, Inc.. The device was registered on January 09, 2023.
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 D IVD