Device classification

Respiratory Syncytial Virus, Antigen, Antibody, Ifa

Microbiology · 21 CFR 866.3480

Class IProduct code LKTExempt
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
LKT
Review panel
MI
Medical specialty
MI
Device name
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Medical specialty description
Microbiology
Device class
1
Regulation number
866.3480
Implant flag
N
Submission type ID
4
Harmonized identifiers (openFDA)
K number
K943317, K871230, K842047, K942173, K831924, K872701, K884192, K841527, K852472, K844721, K081928, K872082, K861379, K873564, K870176, K912371, K852185, K862321, K912838, K894623, K912842, K983336, K882687
Registration number
3003750284, 1528450, 1181055, 3004973408, 1419968
FEI number
3003750284, 1181055, 3004973408, 1419968, 1000122536
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.