Identity
- Trade Name
- NOVA Lite® Auto AB Panel FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, control FDA UDI
- Device Name
- 1. 1x 0.5mL ANA Homogeneous/dsDNA pattern 2. 1x 0.5 ANA Speckled Pattern 3. 1x 0.5 ANA Nucleolar Pattern 4. 1x 0.5 ANA Centromere pattern 5. 1x 0.5 ANA Scl-70 pattern FDA UDI
- Model / Reference
- 708180 FDA UDI
- Description
- 1. 1x 0.5mL ANA Homogeneous/dsDNA pattern 2. 1x 0.5 ANA Speckled Pattern 3. 1x 0.5 ANA Nucleolar Pattern 4. 1x 0.5 ANA Centromere pattern 5. 1x 0.5 ANA Scl-70 pattern FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950594857 FDA UDI
- 510(k) Number
- K881340 FDA UDI
- FDA Product Code
- LLL FDA UDI
- GMDN Term
- Multiple antinuclear antibody (ANA) screening IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 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 antinuclear antibody (ANA) screening IVD, control
NOVA Lite® Auto AB Panel by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple antinuclear antibody (ANA) screening IVD, control.
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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 28e8191a-924e-425f-8690-04929211f4b2 36 fields · synced May 30, 2026