Duns Number:188354831
Device Description: 1. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide2. 1 x 15mL FITC Anti-Human IgG 1. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide2. 1 x 15mL FITC Anti-Human IgG Conjugate with DAPI3. 1 x 0.5mL dsDNA Positive4. 1 x 0.5mL IFA System Negative Control5. 2 x 25mL PBS II Concentrate (40x)6. 1 x 7mL Mounting Medium7. 1 x 20 Coverslips
Catalog Number
-
Brand Name
NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit
Version/Model Number
708215
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192916
Product Code
KTL
Product Code Name
Anti-Dna Indirect Immunofluorescent Solid Phase
Public Device Record Key
84c4e428-3b3a-4c7e-a1ea-d2337316d780
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 215 |