FDA device listing
20X SSC, 500g,Abbott Bisulfite Modification Kit,Abbott mSample Preparation System Bulk mLysis DNA Buffer,Abbott…
FDA device listing 1091700756 · ABBOTT LABORATORIES
Key facts
| Proprietary names | 20X SSC, 500g,Abbott Bisulfite Modification Kit,Abbott mSample Preparation System Bulk mLysis DNA Buffer,Abbott Proteinase K,Alcohol Diluent GPR 60 mL,Alinity h-series AutoClean Solution (LN 01R5104),AMP Check E GPR,Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (1000 mL),Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (100 mL),Antibody Diluent DF 2X NAD and G6P GPR (1000 mL),Antibody Diluent… |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | PPM |
| Device names | PPM - General Purpose Reagent |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| Registered establishments | ABBOTT GmbH, ABBOTT LABORATORIES, Abbott Molecular Distribution Center, ABBOTT MOLECULAR, INC., Alere San Diego, Inc. |
| Establishment registrations | 2020952, 3002809144, 3005248192, 3005333358, 3016438761, 3019837962 |
| FEI numbers | 2020952, 3002809144, 3005248192, 3005333358, 3016438761, 3019837962 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer, Specification Developer, U.S. Manufacturer of Export Only Devices |
| 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