| Device Classification Name |
respiratory virus panel nucleic acid assay system
|
|---|
| 510(K) Number |
K103776 |
|---|
| Model |
I025C0197, 5N01-01, S025-0245, 5N01-10
|
| Device Name |
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST |
|---|
| Applicant |
| LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| 439 university ave. |
| suite 900 |
|
toronto, ontario,
|
|
| Contact |
lubna syed |
| Regulation Number | 866.3980
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 12/27/2010 |
|---|
| Decision Date | 07/01/2011 |
|---|
| Decision |
substantially equivalent - CLIA submission (CS) |
|---|
| Classification Advisory Committee |
Microbiology
|
|---|
| Review Advisory Committee |
Microbiology
|
|---|
| summary |
summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
