Duns Number:606034197
Device Description: ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA.
Catalog Number
THROMBOTYPE
Brand Name
ThromboType®
Version/Model Number
THROMBOTYPE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 15, 2018
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
BK050040
Product Code
MYP
Product Code Name
Test,Platelet Antibody
Public Device Record Key
c6ce24bf-c08c-44b8-8f34-2e0ebf4b23f1
Public Version Date
August 15, 2018
Public Version Number
5
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 |