Product code PCL

Device name
Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Medical specialty
Microbiology
Device class
1
Regulation number
866.3520
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
The qualitative detection of measles specific IgM antibodies in serum or plasma.
Source
FDA openFDA device classification dataset