Identity
- Trade Name
- NOVA Lite EUDAMEDNOVA Lite® ANCA Formalin Kit FDA UDI
- Generic Name
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- NOVA Lite® ANCA Formalin Kit EUDAMED1. 10x 6-well ANCA Neutrophil substrate slides (formalin-fixed) 2. 1x 1mL pANCA Positive Control (prediluted) 3. 1x 1mL ANA Positive Control (prediluted) 4. 1x 1mL IFA System Negative Control 5. 1x7mL anti Human IgG AFF Fluorescein with Evans Blue 6. 2x 25mL PBS II Concentrate (40x) 7. 1x 3mL 1% Evans Blue Counterstain 8. 1x 3mL Mounting Medium 9. 1x 10 Coverslips 10. 1x Instruction leaflet FDA UDI
- Model / Reference
- 708295 EUDAMEDFDA UDI
- Description
- 1. 10x 6-well ANCA Neutrophil substrate slides (formalin-fixed) 2. 1x 1mL pANCA Positive Control (prediluted) 3. 1x 1mL ANA Positive Control (prediluted) 4. 1x 1mL IFA System Negative Control 5. 1x7mL anti Human IgG AFF Fluorescein with Evans Blue 6. 2x 25mL PBS II Concentrate (40x) 7. 1x 3mL 1% Evans Blue Counterstain 8. 1x 3mL Mounting Medium 9. 1x 10 Coverslips 10. 1x Instruction leaflet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950554103 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950554103 EUDAMED
- 510(k) Number
- K965133 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-08426950554103 | 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 d5e41b88-8751-4e92-bc50-ab96b957750e 61 fields · synced May 30, 2026
- FDA UDI 04b9ffd6-fb86-41e8-a1af-60ac30576d3a 36 fields · synced May 30, 2026