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

Zika Virus Serological Reagents (Emergency Use)

Unknown
FDA source (opens on fda.gov)

PYS is the FDA product code for Zika Virus Serological Reagents (Emergency Use). FDA's definition for this code reads: "Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PYS
Device name
Zika Virus Serological Reagents (Emergency Use)
FDA definition
Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.
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
0

Companies listing this code with FDA

Companies whose registered establishments list this code