FDA device listing
32A Automated Viral DNA/RNA Isolation Kit,96A Automated Viral DNA/RNA Isolation Kit,ANDiS Viral RNA Auto Extraction &…
FDA device listing 1852971259 · 3D Biomedicine Science & Technology Co., Limited
Key facts
| Proprietary names | 32A Automated Viral DNA/RNA Isolation Kit,96A Automated Viral DNA/RNA Isolation Kit,ANDiS Viral RNA Auto Extraction & Purification Kit,Automated Nucleic Acids Extraction System ANDiS 396,ReadiMag™ FFPE DNA Isolation Kit,ReadiMag FFPE DNA/RNA Kit,ReadiMag™ gDNA Isolation Kit,ReadiMag Pathogen Nucleic Acid Isolation Kit |
|---|---|
| Owner/operator | 3D Biomedicine Science & Technology Co., Limited |
| Owner/operator number | 10063312 |
| Product codes | JJH |
| Device names | JJH - Clinical Sample Concentrator |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2310 |
| Review panels | Clinical Chemistry |
| Registered establishments | 3D BIOMEDICINE SCIENCE & TECHNOLOGY CO., LIMITED |
| Establishment registrations | 3016764493 |
| FEI numbers | 3016764493 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database