Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
The Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens is an in vitro diagnostic device intended for the detection of antigens from microbial agents classified as biothreat agents in specimens from patients with signs and symptoms of infection or known/suspected exposure, and may also be used for cadaver testing when a cadaver constitutes a source of human-to-human transmission. It is classified as FDA Class 2, requiring 510(k) clearance, regulated under 21 CFR 866.4002 within the Microbiology medical specialty. The product code is QID, and this device is flagged as life-sustaining due to its role in diagnosing potentially fatal biothreat infections.
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Basic Information
- Product Code
- QID
- Device Class
- FDA class 2
- Regulation Number
- 866.4002
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure. Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN190025 | OraQuick Ebola Rapid Antigen Test | Oct 10, 2019 | Unknown | OraSure Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.