Brand Name | API® NH TEST STRIP |
Type of Device | API® NH TEST STRIP |
Manufacturer (Section D) |
BIOMERIEUX, SA |
3 route de port michaud |
la balme, les grottes isere 38390 |
FR 38390 |
|
MDR Report Key | 8345218 |
MDR Text Key | 140005697 |
Report Number | 9615754-2019-00010 |
Device Sequence Number | 1 |
Product Code |
JTO
|
UDI-Device Identifier | 03573026035600 |
UDI-Public | 03573026035600 |
Combination Product (y/n) | N |
PMA/PMN Number | C1 EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup |
Report Date |
04/02/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/15/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/22/2019 |
Device Catalogue Number | 10400 |
Device Lot Number | 1006780880 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/07/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|