Identity
- Trade Name
- NOVA Lite® ANA Kit with DAPI FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- 1. 20x ANA Hep- 2 -QR Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate with DAPI 4. 1x 7mL Mounting Medium 5. 2x 25mL PBS II Concentrate (40x) 6 .1x Coverlips, 20 each 7. 1x 0.5mL ANA Titratable Pattern FDA UDI
- Model / Reference
- 708102 FDA UDI
- Description
- 1. 20x ANA Hep- 2 -QR Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate with DAPI 4. 1x 7mL Mounting Medium 5. 2x 25mL PBS II Concentrate (40x) 6 .1x Coverlips, 20 each 7. 1x 0.5mL ANA Titratable Pattern FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950593577 FDA UDI
- 510(k) Number
- K880736 FDA UDI
- FDA Product Code
- LLL FDA UDI
- GMDN Term
- Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 FDA UDI
- Commercial Distribution
- Not 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
NOVA Lite® ANA Kit with DAPI by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI 24cd0474-ee85-47f4-9365-70656b7e93e6 37 fields · synced May 30, 2026