Duns Number:557223252
Device Description: HemosIL HIT-Ab(PF4-H)
Catalog Number
00020014600
Brand Name
HemosIL HIT-Ab(PF4-H)
Version/Model Number
00020014600
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
K153137
Product Code
LCO
Product Code Name
PLATELET FACTOR 4 RADIOIMMUNOASSAY
Public Device Record Key
75e22346-4403-4794-8573-894fda533f9b
Public Version Date
July 14, 2021
Public Version Number
6
DI Record Publish Date
September 23, 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. | 272 |