FDA device listing
Ictotest Reagent Tablets for Urinalysis,Ictotest Test for Urinary Bilirubin
FDA device listing 1935277523 · VWR INTERNATIONAL, LLC
Key facts
| Proprietary names | Ictotest Reagent Tablets for Urinalysis,Ictotest Test for Urinary Bilirubin |
|---|---|
| Owner/operator | VWR INTERNATIONAL, LLC |
| Owner/operator number | 9009749 |
| Product codes | JJB |
| Device names | JJB - Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1115 |
| Review panels | Clinical Chemistry |
| Registered establishments | VWR CHEMICALS, LLC |
| Establishment registrations | 1550222 |
| FEI numbers | 1550222 |
| Establishment operations | Contract Manufacturer |
| 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