Identity
- Trade Name
- HEMOSIL RIVAROXABAN CALIBRATORS FDA UDI
- Generic Name
- Coagulation factor Xa inhibitor IVD, calibrator FDA UDI
- Device Name
- 1. Rivaroxaban Calibrator 1 (Cat. No. 0020015410): 5 x 1mL vials 2. Rivaroxaban Calibrator 2 (Cat. No. 0020015420) : 5 x 1mL vials FDA UDI
- Model / Reference
- 0020015400 FDA UDI
- Description
- 1. Rivaroxaban Calibrator 1 (Cat. No. 0020015410): 5 x 1mL vials 2. Rivaroxaban Calibrator 2 (Cat. No. 0020015420) : 5 x 1mL vials FDA UDI
Identifiers
- Catalog Number
- 00020015400 FDA UDI
- Primary DI / UDI-DI
- 08430793243001 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Coagulation factor Xa inhibitor IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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, calibrator
Hemosil Rivaroxaban Calibrators by Instrumentation Laboratory Company — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation factor Xa inhibitor IVD, calibrator.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (2)
- FDA UDI 139b4f04-68e8-4df2-a0df-9ae3adc7b6f6 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026