Status COVID-19/Flu A&B
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Status™ COVID-19/Flu FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Status COVID-19/Flu EUDAMEDStatus™ COVID-19/Flu A&B Antigen test kit, 25 tests FDA UDI
- Model / Reference
- 33225 EUDAMEDBSP-511-25 FDA UDI
- Description
- Status™ COVID-19/Flu A&B Antigen test kit, 25 tests FDA UDI
Identifiers
- Catalog Number
- BSP-511-25 FDA UDI
- Primary DI / UDI-DI
- 10743816001553 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10743816001553 EUDAMED
- 510(k) Number
- K251538 FDA 510(k)
- FDA Product Code
- SCA FDA 510(k)QKP FDA UDIPSZ FDA UDI
- EMDN Code
- W0105090601 CORONAVIRUS / INFLUENZA - RT & POC EUDAMED
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)N FDA UDI
- Legislation / Framework
- 21 CFR Part 866.3987 FDA 510(k)
- Regulation Number
- 866.3987 FDA 510(k)866.3328 FDA UDI
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
Yes
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Status COVID-19/Flu A&B is a Multi-Analyte Respiratory Virus Antigen Detection Test, designed to simultaneously identify antigens for SARS-CoV-2 (COVID-19), Influenza A, and Influenza B viruses in clinical specimens. This rapid diagnostic device provides qualitative results for multiple respiratory pathogens, aiding in the differential diagnosis of acute respiratory infections.
This test is intended for in vitro diagnostic use and is supplied as a single-use cassette. It is classified under EU IVDD and cleared by the FDA via 510(k) under the Dual Track pathway, with a device classification of Class II. The device requires refrigerated storage and is intended for professional use in microbiology settings, adhering to regulatory standards for respiratory virus detection.
Frequently asked questions
What types of respiratory viruses can the Status COVID-19/Flu A&B test detect simultaneously, and how does this help in clinical decision-making?
The Status COVID-19/Flu A&B test is designed to detect antigens for SARS-CoV-2 (COVID-19), Influenza A, and Influenza B in a single clinical specimen. This simultaneous detection aids clinicians in differentiating between these common respiratory pathogens, enabling faster and more accurate diagnosis of acute respiratory infections. This is particularly useful during overlapping outbreaks or when symptoms alone are ambiguous.
Is the Status COVID-19/Flu A&B test intended for single-use only, and if so, what does this mean for workflow efficiency in a clinical lab?
Yes, the Status COVID-19/Flu A&B is supplied as a single-use cassette, meaning each test is intended for one-time use only. This design ensures sterility and reduces the risk of cross-contamination between samples. For clinical workflows, this means labs will need to prepare one cassette per test, but it also minimizes waste and simplifies inventory management since no reprocessing or sterilization is required.
What storage conditions are required for the Status COVID-19/Flu A&B test, and why is this important for maintaining its performance?
The test requires refrigerated storage, which helps preserve its stability and accuracy. Proper refrigeration ensures the antigens and reagents remain effective for detecting SARS-CoV-2, Influenza A, and Influenza B. Failure to store it under refrigeration could compromise test performance, leading to unreliable results. Always follow the manufacturer’s guidelines for storage temperature ranges.
Is this test approved for use in all clinical settings, or is it specifically intended for professional use in microbiology labs?
The Status COVID-19/Flu A&B is intended for professional use in microbiology settings, as indicated in the regulatory documentation. While it is cleared for in vitro diagnostic use, its design and performance are optimized for trained personnel in clinical labs or point-of-care settings with microbiology expertise. It is not intended for home or self-testing.
What regulatory pathways were followed for the FDA clearance and EU IVDD classification of this device, and how does this affect its adoption?
The device was cleared by the FDA via the 510(k) Dual Track pathway under the Microbiology advisory committee, with a classification of Class II, indicating a moderate risk level. It is also classified under the EU In Vitro Diagnostic Device Directive (IVDD). These pathways ensure the test meets stringent standards for safety, performance, and clinical utility, which helps build confidence in its adoption for respiratory virus detection in both U.S. and EU markets.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251538 | Class II | Active |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (3)
- FDA 510(k) K251538 24 fields · synced Sep 18, 2026
- FDA UDI fbc24eb4-9f87-4275-bf5c-7796898fb73b 36 fields · synced May 30, 2026
- EUDAMED 1a890d54-3ce7-4599-b725-a856bcdfc258 61 fields · synced Jul 16, 2026