Duns Number:079935300
Device Description: AMA-M2 IgG ELISA
Catalog Number
5163G
Brand Name
Immco Diagnostics, Inc.
Version/Model Number
5163G
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2021
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"
Yes
For Single-Use
-
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
-
Product Code
DBM
Product Code Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Public Device Record Key
ee3b4d82-736d-4ffe-9aed-5402db53bd97
Public Version Date
August 16, 2022
Public Version Number
4
DI Record Publish Date
September 07, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 185 |