Duns Number:188354831
Device Description: 1. 5 x 12-well HEp-2 Substrate Slides2. 1 x 4mL FITC Anti-Human IgG Conjugate3. 1 x 0.5 mL 1. 5 x 12-well HEp-2 Substrate Slides2. 1 x 4mL FITC Anti-Human IgG Conjugate3. 1 x 0.5 mL ANA Titratable Endpoint Pattern Control4. 1 x 0.5mL IFA System Negative Control5. 1 x 25mL PBS II Concentrate (40x)6. 1 x 7mL Mounting Medium7. 1 x 20 Coverslips
Catalog Number
-
Brand Name
NOVA Lite® HEp-2 ANA Kit
Version/Model Number
708101
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
K880736
Product Code
LLL
Product Code Name
Extractable Antinuclear Antibody, Antigen And Control
Public Device Record Key
04c41565-79f3-4ecf-878d-4a1f361dd709
Public Version Date
July 06, 2018
Public Version Number
3
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 |