FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NOVA Gel® Sm/RNP “T” Extractable Autoantibody Reagents
DI: 08426950593966
·
Model: 708415
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NOVA Gel® Sm/RNP “T” Extractable Autoantibody Reagents
- Primary DI
- 08426950593966
- Version / Model
- 708415
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- f7f4dff7-48c4-4448-9ede-cfd3ed3bd1d4
- Distribution End Date
- 2018-05-02
Device Description
1. 8 prepunched NOVA Gel titering ""T"" plates 2. 2 0.4mL Sm/RNP antigen, lyophilized 3. 1 0.7mL Sm Control 4. 1 0.7mL RNP Control
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 |
|---|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | Immunology | 866.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54825 | Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for multiple types of antibodies to extractable nuclear antigens (anti-ENA) in a clinical specimen, using a precipitation/immunodiffusion method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950593966 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius