Duns Number:623214079
Device Description: Captia™ Cytomegalovirus IgM
Catalog Number
2325260
Brand Name
Trinity Biotech
Version/Model Number
2325260
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K921011
Product Code
LFZ
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Public Device Record Key
6a9fefbc-73b7-4986-b47b-35456b13d595
Public Version Date
November 06, 2019
Public Version Number
4
DI Record Publish Date
September 21, 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 | 50 |
2 | A medical device with a moderate to high risk that requires special controls. | 116 |