Data / Medical devices / System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test (NTW): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test (product code NTW, Class 2, 21 CFR 866.4070). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on February 4, 2009, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NTW
- Device class
- 2
- Regulation
- 866.4070
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United Kingdom | 1 |
| Switzerland | 1 |
| Germany | 1 |
Makers of System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Company (BD) | Plymouth Devon, United Kingdom | Contract manufacturer, Manufacturer | 1 | February 4, 2009 | 0 | 0 | 0 | api.fda.gov |
| Preanalytix GMBH | HOMBRECHTIKON Zurich, Switzerland | Specification developer | 1 | February 4, 2009 | 0 | 0 | 0 | api.fda.gov |
| Qiagen, GMBH | HILDEN North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 4, 2009. 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.