CREDO DIAGNOSTICS BIOMEDICAL PTE · 89-08 · SINGAPORE

For CREDO DIAGNOSTICS BIOMEDICAL PTE, import alert is 89-08; country is SINGAPORE; 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)"; 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 2026-09-30.

What the source says

CREDO DIAGNOSTICS BIOMEDICAL PTE Date Published : 09/30/2021 1 Fifth Avenue , Guthrie House , Singapore, SINGAPORE

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.