Identity
- Trade Name
- HEMOSIL RIVAROXABAN CONTROLS FDA UDI
- Generic Name
- Coagulation factor Xa inhibitor IVD, control FDA UDI
- Device Name
- 1. Rivaroxaban Low Control (Cat. No. 0020015510): 5 x 1mL vials 2. Rivaroxaban High Control (Cat. No. 0020015520): 5 x 1mL vials FDA UDI
- Model / Reference
- 0020015500 FDA UDI
- Description
- 1. Rivaroxaban Low Control (Cat. No. 0020015510): 5 x 1mL vials 2. Rivaroxaban High Control (Cat. No. 0020015520): 5 x 1mL vials FDA UDI
Identifiers
- Catalog Number
- 00020015500 FDA UDI
- Primary DI / UDI-DI
- 08430793242998 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Coagulation factor Xa inhibitor 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coagulation factor Xa inhibitor IVD, control
Hemosil Rivaroxaban Controls by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation factor Xa inhibitor IVD, control.
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
- Instrumentation Laboratory Company
Sources (1)
- FDA UDI d791a557-6eed-4470-81b0-b99e823c75de 36 fields · synced Jun 8, 2026