Brand Name | VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT |
Type of Device | VITEK® 2 NH ID TEST KIT |
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 | 6793974 |
MDR Text Key | 83749418 |
Report Number | 1950204-2017-00268 |
Device Sequence Number | 1 |
Product Code |
JST
|
UDI-Device Identifier | 03573026144357 |
UDI-Public | 03573026144357 |
Combination Product (y/n) | N |
Reporter Country Code | PL |
PMA/PMN Number | CL. I EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/04/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/07/2018 |
Device Catalogue Number | 21346 |
Device Lot Number | 2450285403 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/24/2017
|
Initial Date FDA Received | 08/15/2017 |
Supplement Dates Manufacturer Received | 11/09/2017
|
Supplement Dates FDA Received | 12/04/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/08/2017 |
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 |
|
|