Brand Name | VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT |
Type of Device | VITEK® 2 GP ID CARD |
Manufacturer (Section D) |
BIOMERIEUX, INC |
595 anglum road |
st. louis MO 63042 |
|
Manufacturer (Section G) |
BIOMERIEUX, INC |
595 anglum road |
|
st. louis MO 63042 |
|
Manufacturer Contact |
ellen
weltmer
|
595 anglum road |
hazelwood, MO 63042
|
3147317301
|
|
MDR Report Key | 5917841 |
MDR Text Key | 53671213 |
Report Number | 1950204-2016-00114 |
Device Sequence Number | 1 |
Product Code |
LQL
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K952095 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
08/09/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/31/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/18/2017 |
Device Catalogue Number | 21342 |
Device Lot Number | 242396140 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/09/2016 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 04/18/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|