Identity
- Trade Name
- Aptiva® APS IgM Calibrators EUDAMEDFDA UDI
- Generic Name
- Anticardiolipin antibody IVD, calibrator FDA UDI
- Device Name
- Aptiva® APS IgM Calibrators EUDAMED1.Aptiva APS IgM Calibrator 1 (2x0.3mL) 2. Aptiva APS IgM Calibrator 2 (2x0.3mL) 3. Aptiva APS IgM Calibrator 3 (2x0.3mL) FDA UDI
- Model / Reference
- 725141 EUDAMEDFDA UDI
- Description
- 1.Aptiva APS IgM Calibrator 1 (2x0.3mL) 2. Aptiva APS IgM Calibrator 2 (2x0.3mL) 3. Aptiva APS IgM Calibrator 3 (2x0.3mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08430793040907 EUDAMEDFDA UDI
- Basic UDI-DI
- 843079304090743 EUDAMED
- FDA Product Code
- JIX FDA UDI
- EMDN Code
- W0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMED
- GMDN Term
- Anticardiolipin antibody IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Aptiva® APS IgM Calibrators by Inova Diagnostics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 843079304090743 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED cdd1d777-d351-42c5-957b-456706cacc4d 61 fields · synced Jul 19, 2026
- FDA UDI b12ad46f-2cec-40ca-9d1e-f3c8dbb0ea6a 35 fields · synced May 30, 2026