LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
FDA 510(k) K192046 · DiaSorin, Inc.
Submission
- Device name
- LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- July 31, 2019
- Decision date
- October 28, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QFO – Zika Virus Serological Reagents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3935
- Specialty
- Microbiology
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…
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| K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50…QFO · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/17/2019SE |
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Questions and answers
When was LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set cleared by the FDA?
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set (K192046) received a 510(k) decision of Substantially Equivalent on October 28, 2019, 89 days after the submission was received.
What is the product code of K192046?
The FDA product code is QFO – Zika Virus Serological Reagents, a Class II (moderate risk) device regulated under 21 CFR 866.3935.