Data / Medical devices / Australia / Genetic Signatures Limited
Genetic Signatures Limited: FDA-registered device maker in Newtown New South Wales, Australia, 1 510(k) clearance
Genetic Signatures Limited is registered with the FDA (registration 3011781554) in Newtown New South Wales, Australia. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 29, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011781554
- Address
- 7 Eliza St, Newtown New South Wales, Australia, 2042
- Owner or operator
- Genetic Signatures Limited (10049463)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 3, 2015
- Registered through
- 2026
- Brand names listed
- 3base ASRs, EasyScreen Gastrointestinal Parasite Detection Kit, EasyScreen Sample Processing Kit SP001, EasyScreen Sample Processing Kit SP005, EasyScreen Sample Processing Kit SP006, EasyScreen Sample Processing Kit SP008, EasyScreen Sample Processing Kit SP008v2, EasyScreen Sample Processing Kit SP012
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | 1 | Manufacturer | accessdata.fda.gov |
| Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | PCH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 29, 2024 | K232672 | EasyScreen Gastrointestinal Parasite Detection Kit | PCH | Substantially Equivalent | Genetic Signatures Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Clinical Sample Concentrator
- All makers of Real Time Nucleic Acid Amplification System
- All makers of Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- All makers of Reagents, Specific, Analyte
Updated May 29, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.