Identity
- Trade Name
- Aptiva® APS IgM Reagent EUDAMEDFDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Aptiva® APS IgM Reagent EUDAMED1.Aptiva APS IgM Reagent Cartridge -APS IgM Beads (1x0.5mL) -Assay Buffer (1x17mL) -PE Tracer IgM (1x17mL) -Hydration Buffer (1x6.5mL) FDA UDI
- Model / Reference
- 725140 EUDAMEDFDA UDI
- Description
- 1.Aptiva APS IgM Reagent Cartridge -APS IgM Beads (1x0.5mL) -Assay Buffer (1x17mL) -PE Tracer IgM (1x17mL) -Hydration Buffer (1x6.5mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08430793040853 EUDAMEDFDA UDI
- Basic UDI-DI
- 843079304085345 EUDAMED
- 510(k) Number
- K223093 FDA UDI
- FDA Product Code
- MID FDA UDIMSV FDA UDI
- EMDN Code
- W0102100501,W0102100503 EUDAMED
- GMDN Term
- Anticardiolipin antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5660 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
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
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 Reagent 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 | 843079304085345 | 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 75e8d2a7-ed14-4d28-97d2-40bd5aab4941 61 fields · synced Jul 30, 2026
- FDA UDI 8d501857-2123-47a9-b0dd-d2d2b906920c 36 fields · synced May 30, 2026