# CREDO DIAGNOSTICS BIOMEDICAL PTE · 89-08 · SINGAPORE — FDA import alert red lists: firms subject to detention without physical examination

For CREDO DIAGNOSTICS BIOMEDICAL PTE · 89-08 · SINGAPORE, 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 SINGAPORE; product is VitaPCR Instrument -VitaPCR SARS-CoV-2 Gen 2 Assay | VitaPCR SARS-CoV-2 Gen2 External Control Set; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 09/30/2021; address is 1 Fifth Avenue , Guthrie House , Singapore, SINGAPORE, verified against its source on 2026-09-16.

- **Firm:** CREDO DIAGNOSTICS BIOMEDICAL PTE _(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:** SINGAPORE _(verified: appears in the quote below)_
- **Address:** 1 Fifth Avenue , Guthrie House , Singapore, SINGAPORE _(verified: appears in the quote below)_
- **Date published:** 09/30/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: each item appears in the quote below)_
- **Product:** VitaPCR Instrument -VitaPCR SARS-CoV-2 Gen 2 Assay | VitaPCR SARS-CoV-2 Gen2 External Control Set _(verified: each item appears in the quote below)_

## What the source says

> CREDO DIAGNOSTICS BIOMEDICAL PTE Date Published : 09/30/2021 1 Fifth Avenue , Guthrie House , Singapore, SINGAPORE 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: VitaPCR Instrument -VitaPCR SARS-CoV-2 Gen 2 Assay 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: VitaPCR SARS-CoV-2 Gen2 External Control Set

## 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/).