Identity
- Trade Name
- NOVA Lite® ANCA Kit FDA UDI
- Generic Name
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- 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
- Model / Reference
- 708296 FDA 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
- 08426950513995 FDA UDI
- 510(k) Number
- K961340 FDA UDI
- FDA Product Code
- MOB FDA UDI
- GMDN Term
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
NOVA Lite® ANCA Kit by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI d0742eb7-9649-45fc-8ca8-149e2ec1c606 36 fields · synced Jun 8, 2026