Brand Name | HEA 1.2 BEADCHIP KIT, SLIDE |
Type of Device | HEA 1.2 BEADCHIP KIT, SLIDE |
Manufacturer (Section D) |
BIOARRAY SOLUTIONS LTD. |
35 technology drive |
suite 100 |
warren NJ 07059 |
|
Manufacturer Contact |
luz
villamizar
|
35 technology drive |
suite 100 |
warren, NJ 07059
|
9084449591
|
|
MDR Report Key | 9071196 |
MDR Text Key | 191919543 |
Report Number | 3005967741-2019-00016 |
Device Sequence Number | 1 |
Product Code |
PEP
|
UDI-Device Identifier | 10888234100065 |
UDI-Public | 10888234100065 |
Combination Product (y/n) | N |
PMA/PMN Number | BP130026 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/16/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/16/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 12/31/2019 |
Device Model Number | 800-10202-08 |
Device Catalogue Number | 800-10202-08 |
Device Lot Number | 18-184-C |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 03/19/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/03/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|