Identity
- Trade Name
- NOVA Lite® Thyroid FDA UDI
- Generic Name
- Multiple thyroid antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- 1. 10x 8-well Thyroid Substrate Slides 2. 1x 7mL FITC IgG Conjugate Primate Absorbed 3. 1x 0.5 mL Thyroid Positive 4. 1x 0.5mL IFA Systems Negative Control 5. 1x 25mL PBS Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 10 Coverslips FDA UDI
- Model / Reference
- 708350 FDA UDI
- Description
- 1. 10x 8-well Thyroid Substrate Slides 2. 1x 7mL FITC IgG Conjugate Primate Absorbed 3. 1x 0.5 mL Thyroid Positive 4. 1x 0.5mL IFA Systems Negative Control 5. 1x 25mL PBS Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 10 Coverslips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950596240 FDA UDI
- 510(k) Number
- K904224 FDA UDI
- FDA Product Code
- JZO FDA UDI
- GMDN Term
- Multiple thyroid antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5870 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 thyroid antibody IVD, kit, fluorescent immunoassay
NOVA Lite® Thyroid 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 946a7734-78d8-4bf5-ad97-e3572d756915 36 fields · synced May 30, 2026