Duns Number:606034197
Device Description: Pak2-LE is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to Pak2-LE is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
Catalog Number
PAK2-LE
Brand Name
Pak2-LE
Version/Model Number
PAK2-LE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 15, 2017
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"
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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
BK950004
Product Code
MYP
Product Code Name
Test,Platelet Antibody
Public Device Record Key
9ac0cd8c-70c5-414c-825c-00583a6c5329
Public Version Date
August 01, 2018
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 |