Last synced on 30 November 2024 at 11:09 am

Zika Virus Serological Reagents (Emergency Use)

Page Type
Product Code
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.
Physical State
In Vitro Diagnostic antigens and antisera
Technical Method
Immunological methods / ELISA
Target Area
The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.
Review Panel
Microbiology
Submission Type
EUA - Emergency Use Authorization
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code PYS is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Zika Virus Serological Reagents (Emergency Use)

Page Type
Product Code
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.
Physical State
In Vitro Diagnostic antigens and antisera
Technical Method
Immunological methods / ELISA
Target Area
The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.
Review Panel
Microbiology
Submission Type
EUA - Emergency Use Authorization
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code PYS is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.