FDA device listing
CMV AMP Check ASR,CMV PRIMER ASR,Cri-du-Chat Region Probe ? Vysis LSI D5S23, D5S721SpectrumGreen Probe,Immunalysis…
FDA device listing 1287176430 · ABBOTT LABORATORIES
Key facts
| Proprietary names | CMV AMP Check ASR,CMV PRIMER ASR,Cri-du-Chat Region Probe ? Vysis LSI D5S23, D5S721SpectrumGreen Probe,Immunalysis Corporation Amphetamine Antibody ASR (1000 mL),Immunalysis Corporation Amphetamine Antibody ASR (100 mL),Immunalysis Corporation Amphetamine Enzyme Conjugate ASR (600 mL),Immunalysis Corporation Amphetamine Enzyme Conjugate ASR (60 mL),Immunalysis Corporation Barbiturates Antibody ASR… |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | MVU |
| Device names | MVU - Reagents, Specific, Analyte |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4020 |
| Review panels | Pathology |
| Registered establishments | ABBOTT MOLECULAR, INC., Alere San Diego, Inc. |
| Establishment registrations | 2020952, 3005248192 |
| FEI numbers | 2020952, 3005248192 |
| 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