Duns Number:188354831
Device Description: 1. 1 x 7mL Mounting Medium2. 1 x 15mL FITC IgG Conjugate with DAPI3. 1 x Coverslips (20 ea 1. 1 x 7mL Mounting Medium2. 1 x 15mL FITC IgG Conjugate with DAPI3. 1 x Coverslips (20 ea)4. 1 x 0.5mL IFA System Negative Control5. 1 x 0.5mL cANCA Positive6. 1 x 0.5mL pANCA Positive7. 20 x ANCA (Formalin Fixed Human Neutrophil) Slide (12 well)8. 2 x 25mL PBS II Concentrate (40x)
Catalog Number
-
Brand Name
NOVA Lite® DAPI ANCA (Formalin) Kit
Version/Model Number
704337
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
K161258
Product Code
MOB
Product Code Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Public Device Record Key
eee15cce-f4e2-4125-b19d-cac9f961aff3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 12, 2017
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 |