Duns Number:611245549
Device Description: The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.
Catalog Number
4036028
Brand Name
Heparin/PF4 Antibody Serum Panel
Version/Model Number
4036028
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
K052697,K052697
Product Code
GGN
Product Code Name
Plasma, Coagulation Control
Public Device Record Key
02b7de8e-66e6-4d50-983b-4754dc9a622f
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 05, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-