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Zika Virus Serological Reagents (Emergency Use)

PYS · Not classified · Unknown

Classification

FDA Product Code
PYS
Device class
Not classified
Regulation
Review panel
MI
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
2

Source

Authoritative
FDA Device Classification database
Machine
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