Brand Name | VIDAS® FT4 ASSAY |
Type of Device | VIDAS® FT4 ASSAY |
Manufacturer (Section D) |
BIOMERIEUX, S.A. |
chemin de l orme |
marcy l etoile, rhone 69280 |
FR 69280 |
|
Manufacturer (Section G) |
BIOMERIEUX, S.A. |
chemin de l orme |
|
marcy l etoile, rhone 69280 |
FR
69280
|
|
Manufacturer Contact |
ellen
weltmer
|
595 anglum road |
st. louis, MO 63042
|
3147317301
|
|
MDR Report Key | 6323117 |
MDR Text Key | 67148661 |
Report Number | 3002769706-2017-00024 |
Device Sequence Number | 1 |
Product Code |
CEC
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K132058 |
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 |
04/04/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/10/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/15/2017 |
Device Catalogue Number | 30459 |
Device Lot Number | 1004988060 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/09/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|