510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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POANot classified

Reagents, Zika Virus Nucleic Acid

Unknown
FDA source (opens on fda.gov)

POA is the FDA product code for Reagents, Zika Virus Nucleic Acid. FDA's definition for this code reads: "Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
POA
Device name
Reagents, Zika Virus Nucleic Acid
FDA definition
Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 8
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code