Last synced on 20 December 2024 at 11:05 pm

Zika Virus Serological Reagents

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; ELISA Kit including different components, i.e., ELISA plates coated with antibodies, other capture antibodies, positive and negative controls etc.
Technical Method
Immunological methods e.g., ELISA
Target Area
Human serum or plasma or whole blood or body fluid collected from patient; none of the body parts will utilize the device or are intended to be affected by the device.
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3935
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QFO is linked to regulation 21CFR866.3935, which does not seem to exist yet. It may be pending at the moment.

Zika Virus Serological Reagents

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; ELISA Kit including different components, i.e., ELISA plates coated with antibodies, other capture antibodies, positive and negative controls etc.
Technical Method
Immunological methods e.g., ELISA
Target Area
Human serum or plasma or whole blood or body fluid collected from patient; none of the body parts will utilize the device or are intended to be affected by the device.
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3935
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QFO is linked to regulation 21CFR866.3935, which does not seem to exist yet. It may be pending at the moment.