BioSign Flu A + B, Status Flu A & B
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133474 FDA 510(k)
- FDA Product Code
- PSZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3328 FDA 510(k)
- Regulation Number
- 866.3328 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BioSign Flu A + B, Status Flu A & B is a rapid diagnostic test designed to detect the presence of Influenza A and B virus antigens. Classified as a device detecting Influenza A, B, and C virus antigens, it provides a qualitative result for the identification of these respiratory pathogens in clinical settings.
This device is intended for single-use in microbiology laboratories and clinical settings. Supplied as a rapid test kit, it requires no special storage conditions beyond refrigeration and is regulated under FDA 510(k) clearance (K133474) and In Vitro Diagnostic Device Directive (IVDD) compliance. The test is non-reusable and does not require MRI safety considerations, adhering to Class II medical device standards.
Frequently asked questions
How is the BioSign Flu A + B, Status Flu A & B test kit supplied and what are its storage requirements?
The BioSign Flu A + B, Status Flu A & B is supplied as a rapid test kit designed for single-use in microbiology laboratories and clinical settings. Storage is straightforward—it only requires refrigeration, so no specialized conditions are needed beyond standard cool temperatures.
Can this device be reused, or is it intended for one-time use only?
This device is explicitly intended for single-use only, as stated in its description. It is not designed or approved for reuse, ensuring safety and accuracy for each test.
What regulatory pathways does the BioSign Flu A + B, Status Flu A & B follow, and how does that affect its use?
The device follows both FDA 510(k) clearance (with clearance number K133474) and In Vitro Diagnostic Device Directive (IVDD) compliance. This means it has undergone regulatory review to ensure its safety and performance for detecting Influenza A and B virus antigens in clinical settings.
Does this test require any special handling or safety considerations, such as MRI compatibility?
No, the BioSign Flu A + B, Status Flu A & B does not require MRI safety considerations. It is a Class II medical device designed for rapid diagnostic use in microbiology and clinical settings, focusing solely on detecting viral antigens without electromagnetic interference concerns.
What types of clinical settings or laboratories is this device intended for?
The device is designed for use in microbiology laboratories and clinical settings where rapid detection of Influenza A and B virus antigens is required. Its classification as a diagnostic test for respiratory pathogens makes it suitable for environments where quick, accurate results are critical for patient care.
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 | K133474 | Class II | Active |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (2)
- FDA 510(k) K133474 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 14, 2026