Brand Name | ID CORE XT |
Type of Device | ANTIGEN GENOTYPING TEST |
Manufacturer (Section D) |
PROGENIKA BIOPHARMA, S.A |
ibaizabal bidea, edificio 504 |
parque tecnol?gico de bizkaia |
derio, bizkaia 48160 |
SP 48160 |
|
Manufacturer (Section G) |
PROGENIKA BIOPHARMA, S.A |
ibaizabal bidea, edificio 504 |
parque tecnol?gico de bizkaia |
derio, bizkaia 48160 |
SP
48160
|
|
Manufacturer Contact |
diego
tejedor
|
ibaizabal bidea, edificio 504 |
parque tecnol?gico de bizkaia |
derio, bizkaia 48160
|
SP
48160
|
|
MDR Report Key | 12878197 |
MDR Text Key | 286059248 |
Report Number | 3006413195-2021-00014 |
Device Sequence Number | 1 |
Product Code |
PEP
|
UDI-Device Identifier | 08437013457019 |
UDI-Public | (01)08437013457019(17)220205(10)0203000023 |
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | BP170154 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/26/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/26/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/05/2022 |
Device Model Number | v3 |
Device Catalogue Number | 1020220034 |
Device Lot Number | 0203000023 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/19/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/10/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
|
|