Device Classification Name |
nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna
|
De Novo Number |
DEN060008 |
510(K) Number |
K060159
|
Device Name |
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET |
Requester |
centers for disease control and prevention |
1600 clifton rd. ne (ms c-12) |
atlanta,
GA
30333
|
|
Contact |
hye-joo kim |
|
Regulation Number | 866.3332
|
Classification Product Code |
|
Date Received | 01/27/2006 |
Decision Date | 02/03/2006 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|