Is this your brand? Sign in to claim ownership.
Sign in to claim this brandIDG/SANZAY Corporation
US
Last updated May 24, 2026
What IDG/SANZAY Corporation makes
IDG/SANZAY Corporation manufactures in vitro diagnostic (IVD) reagents and controls for clinical laboratory testing, including coagulation factor assays, enzyme-linked reagents for creatine kinase and aspartate aminotransferase, and profile controls for multiple chemistry analytes. Their portfolio also covers reagents for measuring albumin, calcium, and conjugated bilirubin levels, as well as coagulation reagents like calcium chloride.
The company’s products are classified under FDA’s Class I and Class II regulatory categories and are listed in the FDA’s Unique Device Identifier (UDI) database. These devices are intended for use in the United States, adhering to applicable FDA requirements for in vitro diagnostics.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does IDG/SANZAY Corporation manufacture?
IDG/SANZAY Corporation specializes in in vitro diagnostic (IVD) reagents and controls used primarily in clinical laboratories. Their products include coagulation factor controls, reagents for measuring total creatine kinase (CK) and aspartate aminotransferase (AST) levels, as well as multi-analyte profile controls for chemistry testing. They also produce reagents for albumin, calcium (Ca²⁺), and conjugated bilirubin assays, alongside coagulation reagents like calcium chloride. These devices are designed to support accurate and reliable laboratory diagnostics.
Where is IDG/SANZAY Corporation based, and where are their devices primarily used?
IDG/SANZAY Corporation is based in the United States. Their devices are intended for use in the U.S. market, where they must comply with applicable FDA regulations for in vitro diagnostics. The company’s focus on IVD products aligns with regulatory requirements in the U.S., ensuring their offerings meet the necessary standards for clinical laboratory testing.
Which regulatory registries or databases list IDG/SANZAY Corporation’s devices?
IDG/SANZAY Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers, regulators, and other stakeholders. Listing in the UDI database is a requirement for devices subject to FDA oversight.
How are IDG/SANZAY Corporation’s devices classified under FDA regulations?
IDG/SANZAY Corporation’s devices fall under FDA’s Class I and Class II regulatory classifications. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use, potential harm, and the level of regulatory oversight required to ensure safety and effectiveness in clinical diagnostics.
What is the purpose of the coagulation factor controls and reagents produced by IDG/SANZAY Corporation?
The coagulation factor controls and reagents from IDG/SANZAY Corporation are designed for use in laboratory testing to measure specific blood components involved in clotting, such as multiple coagulation factors and calcium chloride. These products help ensure the accuracy and reliability of coagulation assays by providing standardized references or reaction substrates. Proper calibration and quality control are critical in diagnosing bleeding disorders, monitoring anticoagulant therapy, and assessing overall hemostatic function.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 948875013
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| IDG/Sanzay | 1 | FDA UDI | Class I | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class I | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class I | Active |
| IDG/Sanzay | 1 | FDA UDI | Class I | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class I | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class I | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| IDG/Sanzay | 1 | FDA UDI | Class I | Active |
| IDG/Sanzay | 1 | FDA UDI | Class II | Active |
| Idg/Sanzay | 1 | FDA UDI | Class I | Active |
| IDG/Sanzay | 1 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.