Duns Number:061446282
Device Description: TPHA Screen Positive Control and TPHA Screen Negative Control are run controls used in the TPHA Screen Positive Control and TPHA Screen Negative Control are run controls used in the TPHA Screen on an automated Blood Bank system. The product configuration is one (1) vial of each control.
Catalog Number
0066828
Brand Name
TPHA Screen Positive Control and TPHA Screen Negative Control
Version/Model Number
0066828
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MYR
Product Code Name
Test,Donor,Syphilis,Antigens,Treponemal
Public Device Record Key
f3adb902-ef46-47cc-8f7b-a0ad35a0a1a7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 15, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| U | Unclassified | 3 |