Duns Number:154281349
Device Description: T. Pallidum IgM Marblot Strip Test System, Western Blot System for the detection of IgM a T. Pallidum IgM Marblot Strip Test System, Western Blot System for the detection of IgM antibody to T. pallidum, 20 Tests
Catalog Number
40-5020M
Brand Name
Trinity Biotech
Version/Model Number
40-5020M
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
JWL
Product Code Name
Antigen, Treponema Pallidum For Fta-Abs Test
Public Device Record Key
ae8caee8-adb3-4ed2-aadb-224fc592a03a
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 |