CREDO DIAGNOSTICS BIOMEDICAL PTE · 89-08 · SINGAPORE
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
- 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
- Address
- 1 Fifth Avenue , Guthrie House , Singapore, SINGAPORE verified
- Date published
- 09/30/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid each item verified
- Product
- VitaPCR Instrument -VitaPCR SARS-CoV-2 Gen 2 Assay | VitaPCR SARS-CoV-2 Gen2 External Control Set each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.