Identity
- Trade Name
- NOVA Lite® dsDNA Crithidia Luciliae FDA UDI
- Generic Name
- Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- 1. 20x 12-well dsDNA Crithidia luciliae Substrate Slides 2. 1x 15mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL dsDNA Positive 4. 1x 0.5mL IFA System Negative Control 5. 2x 25mL PBS II Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 20 Coverslips FDA UDI
- Model / Reference
- 708205 FDA UDI
- Description
- 1. 20x 12-well dsDNA Crithidia luciliae Substrate Slides 2. 1x 15mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL dsDNA Positive 4. 1x 0.5mL IFA System Negative Control 5. 2x 25mL PBS II Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 20 Coverslips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950593904 FDA UDI
- 510(k) Number
- K880742 FDA UDI
- FDA Product Code
- DHN FDA UDI
- GMDN Term
- Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay 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: Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay
NOVA Lite® dsDNA Crithidia Luciliae by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay.
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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 87d6314b-286f-4efd-b065-c75eff4f2e35 36 fields · synced May 30, 2026