Duns Number:061446282
Device Description: Capture-P solid phase system is intended for use in the detection of antibodies to platele Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the five (5) microplate product.
Catalog Number
0066251
Brand Name
Capture-P
Version/Model Number
0066251
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
Yes
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
BK860017
Product Code
KSS
Product Code Name
Supplies, Blood-Bank
Public Device Record Key
3ebc829f-d7bf-412b-8b9f-3f5ead25bbf1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 14, 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. | 58 |
| U | Unclassified | 3 |