Duns Number:188354831
Device Description: 1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 15mL FITC Anti Hu 1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 15mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 2x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 20 Coverslips
Catalog Number
-
Brand Name
NOVA Lite® ANCA Kit
Version/Model Number
708298
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
K961340
Product Code
MOB
Product Code Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Public Device Record Key
a5695dde-44ff-4de1-88d8-81503de7ce5b
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 |