Identity
- Trade Name
- NOVA Lite EUDAMEDNOVA Lite® ANCA Kit FDA UDI
- Generic Name
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- NOVA Lite® ANCA Kit EUDAMED1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides 2. 1x 15mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive 4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control 6. 2x 25mL PBS II Concentrate (40x) 7. 1x 7mL Mounting Medium 8. 1x 20 Coverslips FDA UDI
- Model / Reference
- 708298 EUDAMEDFDA UDI
- Description
- 1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides 2. 1x 15mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive 4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control 6. 2x 25mL PBS II Concentrate (40x) 7. 1x 7mL Mounting Medium 8. 1x 20 Coverslips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950512912 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950512912 EUDAMED
- 510(k) Number
- K961340 FDA UDI
- FDA Product Code
- MOB FDA UDI
- EMDN Code
- W0102100401 ANCA SCREENING EUDAMED
- GMDN Term
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General 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
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
NOVA Lite by Inova Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08426950512912 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | 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 082ff66d-016c-4866-ac5b-d4cc4288c1d6 61 fields · synced Jul 18, 2026
- FDA UDI a5695dde-44ff-4de1-88d8-81503de7ce5b 36 fields · synced May 30, 2026