Brand Name | KIT GRP A STREP 30 TEST VERITOR |
Type of Device | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. |
Manufacturer (Section D) |
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
9 rui pu road export zone b |
suzhou |
CH |
|
Manufacturer (Section G) |
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
9 rui pu road export zone b |
|
suzhou |
CH
|
|
Manufacturer Contact |
jo
doyka
|
7 loveton circle |
sparks, MD 21152
|
4103164000
|
|
MDR Report Key | 18777929 |
MDR Text Key | 336213770 |
Report Number | 3006948883-2024-00027 |
Device Sequence Number | 1 |
Product Code |
GTY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K122718 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/21/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 256040 |
Device Lot Number | 3145731 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/29/2024
|
Initial Date FDA Received | 02/26/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/25/2023 |
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 |
Patient Outcome(s) |
Required Intervention;
|