FDA device listing
3500 Dx Capillary Array 50-cm,3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set,3500 Dx Series 96-Well Standard…
FDA device listing 1296679319 · Life Technologies Corporation
Key facts
| Proprietary names | 3500 Dx Capillary Array 50-cm,3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set,3500 Dx Series 96-Well Standard Retainer & Base Set,3500xL Dx Capillary Array 50-cm,96-Well Septa Dx,Anode Buffer Container Dx,Cathode Buffer Container Dx,CBC Wash Septa Clip Dx,Conditioning Reagent Dx,DS-30 Matrix Standard Kit (Dye Set D) Dx,DS-33 GeneScan™ Install Kit Dx with GeneScan™ 600 LIZ™ v2.0,DS-33… |
|---|---|
| Owner/operator | Life Technologies Corporation |
| Owner/operator number | 9915045 |
| Product codes | PFT |
| Device names | PFT - Reagents For Molecular Diagnostic Test Systems |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.3800 |
| Review panels | Clinical Chemistry |
| Registered establishments | Life Technologies Corporation, LIFE TECHNOLOGIES CORPORATION, Life Technologies Holdings Pte Ltd. |
| Establishment registrations | 3003335080, 3003673482, 3007287152 |
| FEI numbers | 3003335080, 3003673482, 3007287152 |
| Establishment operations | Manufacturer, Specification Developer |
| 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