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Singapore HSA registration DE0506153

Hologic Aptima® BV Assay

Singapore flagSingapore·CLASS B IVD·Hologic, Inc.·Registered September 09, 2021
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0506153
Registration Date
September 09, 2021
Change Notification Approval Date
January 03, 2025
Retention Due Date
September 08, 2025
Product description
The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae. The assay reports a qualitative result for BV and does not report results for individual organisms. The assay is intended to aid in the diagnosis of BV on the automated Panther® system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.
Product Owner
Name
Hologic, Inc.
Short Name
Hologic, Inc.
Address
10210 Genetic Center Drive, San Diego, California 92121, UNITED STATES
Registrant
Name
HOLOGIC SINGAPORE PTE. LTD.
Address
36 ROBINSON ROAD, CITY HOUSE, #10-01-05, SINGAPORE 068877
Importer
Name
ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model information
Model Name(s)
Aptima® BV Assay Aptima® BV Assay Controls Kit Aptima® BV Assay Calibrator
Model Identifier(s)
PRD-05186 PRD-05187 PRD-05188
About this record

Access comprehensive regulatory information for Hologic Aptima® BV Assay 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 DE0506153 and owned by Hologic, Inc.. The device was registered on September 09, 2021.

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