Duns Number:606034197
Device Description: For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)
Catalog Number
403625
Brand Name
Positive Serum Control
Version/Model Number
403625
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053559
Product Code
LCO
Product Code Name
Platelet Factor 4 Radioimmunoassay
Public Device Record Key
63ec7fbe-1995-4dc5-a017-18c9dcd4fbc3
Public Version Date
July 06, 2018
Public Version Number
3
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 |