Duns Number:188354831
Device Description: 1. 25 x Monkey Oesophagus – 10-well slide2. 1 x 1mL Endomysial (Celiac) Positive Control ( 1. 25 x Monkey Oesophagus – 10-well slide2. 1 x 1mL Endomysial (Celiac) Positive Control (prediluted)3. 1 x 1mL IFA System Negative Control (prediluted)4. 2 x 15mL Anti-Human IgA AFF FITC5. 1 x 3mL 1% Evans Blue Counterstain6. 2 x 25mL PBS II concentrate (x40)7. 1 x 10mL Mounting Medium8. 25 x Coverslips 9. 1 x instruction leaflet
Catalog Number
-
Brand Name
NOVA Lite® Monkey Oesophagus IFA Kit
Version/Model Number
704155
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
K981209
Product Code
MVM
Product Code Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Public Device Record Key
01f35a0b-63c8-41f7-93d7-27ce52594c51
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 |