FDA device listing
Dako PT Link,Dako PT Link (PT200),Hybridizer,Hybridizer Humidity Control Strips,Pascal,Pascal Quality Strips,PT Link
FDA device listing 1075647692 · Agilent Technologies, Inc
Key facts
| Proprietary names | Dako PT Link,Dako PT Link (PT200),Hybridizer,Hybridizer Humidity Control Strips,Pascal,Pascal Quality Strips,PT Link |
|---|---|
| Owner/operator | Agilent Technologies, Inc |
| Owner/operator number | 10038794 |
| Product codes | LXG |
| Device names | LXG - Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | Agilent Technologies Denmark ApS, Agilent Technologies Inc., Agilent Technologies LDA, Agilent Technologies Singapore (International) Pte Ltd., ATSI Logistics Center ApS |
| Establishment registrations | 9610099, 3003423869, 3005716001, 3009189893, 3013059683 |
| FEI numbers | 3002806778, 3003423869, 3005716001, 3009189893, 3013059683 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Remanufacturer, Foreign Exporter, Manufacturer, Repackager/Relabeler, 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