Duns Number:155424708
Device Description: AEmA (anti-endomysial) Monkey Esophagus distal 400 Test Kit
Catalog Number
6001-400-ESD
Brand Name
MeDiCa
Version/Model Number
6001-400-ESD
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K993034
Product Code
MVM
Product Code Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Public Device Record Key
73790ad2-773d-4930-af02-23a2efa4808d
Public Version Date
December 09, 2020
Public Version Number
1
DI Record Publish Date
December 01, 2020
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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 240 |