FDA device listing
3500 Dx Capillary Array 50 cm,3500 Dx Genetic Analyzer,3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set,3500 Dx…
FDA device listing 1439742647 · Life Technologies Corporation
Key facts
| Proprietary names | 3500 Dx Capillary Array 50 cm,3500 Dx Genetic Analyzer,3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set,3500 Dx Series 96-Well Standard Retainer & Base Set,3500 Dx Series Data Collection Software 3 IVD v3.2,3500 Dx Series Polymer Pouch Caps,3500 Dx Series Septa 96-Well,3500 Dx Series Septa Cathode Buffer Container,3500xL Dx Capillary Array 50 cm,3500xL Dx Genetic Analyzer,Anode Buffer… |
|---|---|
| Owner/operator | Life Technologies Corporation |
| Owner/operator number | 9915045 |
| Premarket submissions | BK110039 |
| Product codes | PCA |
| Device names | PCA - Dna Genetic Analyzer |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570 |
| Review panels | Clinical Chemistry |
| Registered establishments | LIFE TECHNOLOGIES CORPORATION, Life Technologies Holdings Pte Ltd., Thermo Fisher Scientific Baltics UAB |
| Establishment registrations | 3003673482, 3009573214, 3011104381 |
| FEI numbers | 3003673482, 3009573214, 3011104381 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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