Identity
- Trade Name
- IDG/Sanzay FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- The IDG Control Level 2 Low Abnormal is intended for use for quality assurance of in vitro diagnostic coagulation tests (1-3). The reagent is suitable for use as a low abnormal coagulation time control in the one-stage prothrombin time (PT) assay and in the activated partial thromboplastin time (APTT) assay FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The IDG Control Level 2 Low Abnormal is intended for use for quality assurance of in vitro diagnostic coagulation tests (1-3). The reagent is suitable for use as a low abnormal coagulation time control in the one-stage prothrombin time (PT) assay and in the activated partial thromboplastin time (APTT) assay FDA UDI
Identifiers
- Catalog Number
- HCC2 FDA UDI
- Primary DI / UDI-DI
- 00850053916229 FDA UDI
- 510(k) Number
- K022046 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple coagulation factor IVD, control
IDG/Sanzay by IDG/SANZAY Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- IDG/SANZAY Corporation
Sources (1)
- FDA UDI 10236b6c-8631-4e7a-bf18-ad059385feb9 36 fields · synced May 30, 2026