# Genetic Signatures Limited · 89-08 · AUSTRALIA — FDA import alert red lists: firms subject to detention without physical examination

For Genetic Signatures Limited · 89-08 · AUSTRALIA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is AUSTRALIA; product is EasyScreen SARS-CoV-2 Detection Kit (RP011 & RP011-HT); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 01/21/2022; address is 7 Eliza St , Newtown, New South Wales AUSTRALIA, verified against its source on 2026-09-16.

- **Firm:** Genetic Signatures Limited _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** AUSTRALIA _(verified: appears in the quote below)_
- **Address:** 7 Eliza St , Newtown, New South Wales AUSTRALIA _(verified: appears in the quote below)_
- **Date published:** 01/21/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: appears in the quote below)_
- **Product:** EasyScreen SARS-CoV-2 Detection Kit (RP011 & RP011-HT) _(verified: appears in the quote below)_

## What the source says

> Genetic Signatures Limited Date Published : 01/21/2022 7 Eliza St , Newtown, New South Wales AUSTRALIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 01/21/2022 Desc: EasyScreen SARS-CoV-2 Detection Kit (RP011 & RP011-HT)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).