Duns Number:611245549
Device Description: A collection of reagents and other associated materials intended to be used for the qualit A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to platelet factor 4-heparin complex in a clinical specimen within a short period, relative to standard laboratory testing procedures, using PIFA PLUSS® PF4 Rapid Assay.
Catalog Number
4001101
Brand Name
PIFA PLUSS® PF4 Rapid Assay
Version/Model Number
4001101
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LCO
Product Code Name
Platelet Factor 4 Radioimmunoassay
Public Device Record Key
59a94c8d-76a8-44c1-bdb4-075a6fb862ec
Public Version Date
July 05, 2018
Public Version Number
1
DI Record Publish Date
June 04, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-