Duns Number:606034197
Device Description: PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antib PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum.
Catalog Number
HAT13G
Brand Name
PF4 IgG
Version/Model Number
HAT13G
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
LCO
Product Code Name
Platelet Factor 4 Radioimmunoassay
Public Device Record Key
6175cbee-45b3-4133-b67b-dc99f603a674
Public Version Date
August 06, 2020
Public Version Number
4
DI Record Publish Date
July 08, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |
| U | Unclassified | 36 |