Duns Number:188354831
Device Description: 1. 25 x Rat liver, kidney, stomach slide (10-well)2. 1 x 1mL ANA Homogeneous Pattern (pred 1. 25 x Rat liver, kidney, stomach slide (10-well)2. 1 x 1mL ANA Homogeneous Pattern (prediluted)3. 1 x 1mL IFA System Negative Control (prediluted)4. 1 x 1mL Mitochondrial (AMA) Pattern (prediluted) 5. 1 x 1mL Smooth Muscle (ASMA) Pattern (prediluted) 6. 1 x 15mL FITC IgG (H&L) Conjugate7. 1 x 3mL 1% Evans Blue Counterstain8. 2 x 25 PBS II Buffer (x40 conc)9. 1 x 10mL Mounting Medium10. 50 x Blotters11. 25 x Coverslips 12. 1 x instruction leaflet
Catalog Number
-
Brand Name
NOVA Lite®Rat Liver , Kidney, Stomach Kit
Version/Model Number
704180
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
K955431
Product Code
DBL
Product Code Name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Public Device Record Key
263573c3-aff0-4a69-854e-45e88ecea5e7
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 |