Duns Number:188354831
Device Description: 1. 20x 4-well ANA Plus Substrate Slides2. 1x 15mL FITC Anti-Human IgG Conjugate3. 1x 0.5mL 1. 20x 4-well ANA Plus Substrate Slides2. 1x 15mL FITC Anti-Human IgG Conjugate3. 1x 0.5mL ANA Homogeneous Pattern4. 1x 0.5mL IFA System Negative Control5. 2x 25mL PBS Concentrate (40x)6. 1x 7mL Mounting Medium7. 1x 20 Coverslips
Catalog Number
-
Brand Name
NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach
Version/Model Number
708155
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
K881339
Product Code
LLL
Product Code Name
Extractable Antinuclear Antibody, Antigen And Control
Public Device Record Key
4dc4b3b3-235c-42f5-9aa5-9f59ebe8da31
Public Version Date
June 08, 2021
Public Version Number
4
DI Record Publish Date
August 31, 2016
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 |