Duns Number:154281349
Device Description: Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Control, Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Control, 1 Positive Control and 1 Negative Control
Catalog Number
1206711
Brand Name
Trinity Biotech
Version/Model Number
1206711
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
-
Product Code
LIP
Product Code Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Public Device Record Key
bc679fb2-3d8b-4514-bdcd-e7ce338e60d2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 18, 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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |