Zika Virus Serological Reagents
The Zika Virus Serological Reagents consist of antigens and antisera for the presumptive clinical diagnosis of Zika virus infection in human clinical specimens from individuals with signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors, used in conjunction with other clinical and laboratory findings. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 866.3935 in the Microbiology specialty. The product code is QFO. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QFO
- Device Class
- FDA class 2
- Regulation Number
- 866.3935
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | Jun 03, 2020 | Substantially Equivalent | Chembio Diagnostic Systems |
| K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | Oct 28, 2019 | Substantially Equivalent | DiaSorin, Inc. |
| K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control | Jul 17, 2019 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | May 23, 2019 | Unknown | InBios International, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.