FDA UDI
In Commercial Distribution
🇺🇸 United States
NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit
DI: 08426951056538
·
Model: 708215
·
INOVA DIAGNOSTICS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit
- Primary DI
- 08426951056538
- Version / Model
- 708215
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-31
- Public Version
- 1
- Public Version Date
- 2021-04-08
- Public Version Status
- New
- Public Device Record Key
- 84c4e428-3b3a-4c7e-a1ea-d2337316d780
Device Description
1. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide 2. 1 x 15mL FITC Anti-Human IgG Conjugate with DAPI 3. 1 x 0.5mL dsDNA Positive 4. 1 x 0.5mL IFA System Negative Control 5. 2 x 25mL PBS II Concentrate (40x) 6. 1 x 7mL Mounting Medium 7. 1 x 20 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 |
|---|---|---|---|---|
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | Immunology | 866.5100 | 2 |
| PIV | Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | Immunology | 866.4750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54901 | Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to double stranded DNA (anti-dsDNA) in a clinical specimen, using a fluorescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426951056538 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192916 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius