QFO · Class II · 21 CFR 866.3935

FDA Product Code QFO: Zika Virus Serological Reagents

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.

Leading manufacturers include InBios International, Inc., Siemens Healthcare Diagnostics, Inc. and DiaSorin, Inc..

4
Total
3
Cleared
91d
Avg days
2019
Since

FDA 510(k) Cleared Zika Virus Serological Reagents Devices (Product Code QFO)

4 devices
1–4 of 4
Cleared Jun 03, 2020
DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
K200506
Chembio Diagnostic Systems
Microbiology · 93d
Cleared Oct 28, 2019
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
K192046
DiaSorin, Inc.
Microbiology · 89d
Cleared Jul 17, 2019
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
K191578
Siemens Healthcare Diagnostics, Inc.
Microbiology · 33d
Not Cleared May 23, 2019
ZIKV Detect 2.0 IgM Capture ELISA
DEN180069
InBios International, Inc.
Microbiology · 148d

About Product Code QFO - Regulatory Context