Product code QFO— Microbiology
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
- Classification name
- Zika Virus Serological Reagents
- Device class
- Class 2
- Regulation
- 21 CFR 866.3935
- Advisory panel
- Microbiology
- Total cleared
- 4
- First cleared
- Most recent
FDA classification 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 context for product code QFO
FDA has cleared devices under product code QFO between 2019 and 2020, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2020
- 2019
Top applicants under product code QFO
Recent clearances under product code QFO
- K200506 — DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
- K192046 — LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
- 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
- DEN180069 — ZIKV Detect 2.0 IgM Capture ELISA
Data sourced from openFDA. This site is unofficial and independent of the FDA.