Duns Number:188354831
Device Description: 1. 20x ANCA (Ethanol Fixed Human Neutrophil), slides - 12 wells2. 1x 15mL FITC IgG Conjuga 1. 20x ANCA (Ethanol Fixed Human Neutrophil), slides - 12 wells2. 1x 15mL FITC IgG Conjugate with DAPI 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 Coverslips9. 1x Direction Insert
Catalog Number
-
Brand Name
NOVA Lite® ANCA (Ethanol) Kit with DAPI
Version/Model Number
708301
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 02, 2018
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
c02f2fa2-0c9c-457a-b765-f094cb0af82e
Public Version Date
July 18, 2018
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 |