FDA UDI
In Commercial Distribution
🇺🇸 United States
NOVA Lite® Thyroid
DI: 08426950596240
·
Model: 708350
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NOVA Lite® Thyroid
- Primary DI
- 08426950596240
- Version / Model
- 708350
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 6
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 946a7734-78d8-4bf5-ad97-e3572d756915
Device 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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | Immunology | 866.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55208 | Multiple thyroid antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple antibodies to the thyroid gland and/or specific products of thyroid gland metabolism in a clinical specimen, using a fluorescent immunoassay method. This test detects autoantibodies directed at antigens such as thyroid gland tissue, thyroglobulin, and thyroid peroxidase (TPO) [known as anti-microsomal antibody] to aid in the diagnosis of autoimmune thyroid diseases such as autoimmune thyroiditis (Hashimoto’s disease) and Graves’ disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950596240 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K904224 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius