FDA device listing
60-BA0280 Pointe Barbiturate Reagent,60-BA0284 Pointe Barbiturate Calibrator/Control (Secobarbital 100 ng/mL),60-BA0286…
FDA device listing 1931912303 · HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
Key facts
| Proprietary names | 60-BA0280 Pointe Barbiturate Reagent,60-BA0284 Pointe Barbiturate Calibrator/Control (Secobarbital 100 ng/mL),60-BA0286 Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL),60--BA0288 Pointe Barbiturate Calibrator/Control (Secobarbital 300 ng/mL),60-BA0290 Pointe Barbiturate Calibrator (Secobarbital 1000 ng/mL),60-BA0292 Pointe Barbiturate Control (Secobarbital 400 ng/mL) |
|---|---|
| Owner/operator | HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical |
| Owner/operator number | 10083022 |
| Premarket submissions | K032764 |
| Product codes | DIS, DLJ, LAS |
| Device names | DIS - Enzyme Immunoassay, Barbiturate, DLJ - Calibrators, Drug Specific, LAS - Drug Specific Control Materials |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.3150, 862.3200, 862.3280 |
| Review panels | Clinical Toxicology |
| Registered establishments | HORIBA INSTRUMENTS INCORPORATED |
| Establishment registrations | 1827821 |
| FEI numbers | 1827821 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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