Identity
- Trade Name
- BioSign Flu Controls FDA UDI
- Generic Name
- Nasopharyngeal aspirate container IVD FDA UDI
- Device Name
- BioSign Flu Control Kit (5 Postive/ 5 Negative) FDA UDI
- Model / Reference
- BSP-510C-03 FDA UDI
- Description
- BioSign Flu Control Kit (5 Postive/ 5 Negative) FDA UDI
Identifiers
- Catalog Number
- BSP-510C-03 FDA UDI
- Primary DI / UDI-DI
- 10743816001492 FDA UDI
- GMDN Term
- Nasopharyngeal aspirate container IVD FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Influenza A/B virus antigen IVD, controlNasopharyngeal aspirate container IVDInfluenza A/B virus antigen IVD, reagent
BioSign Flu Controls by Princeton Biomeditech Corp. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Influenza A/B virus antigen IVD, reagent.
- OraSure Quickflu Nasopharyngeal Wash / Aspirate — OraSure Technologies, Inc. · Class I
- OraSure QuickFlu Positive and Negative Control Kit — OraSure Technologies, Inc.
- Status Flu Controls — PRINCETON BIOMEDITECH CORP.
- Status Flu A+B Nasal Wash/Aspirate Kit — PRINCETON BIOMEDITECH CORP. · Class I
- BioSign Flu A+B Nasal Wash/Aspirate Kit — PRINCETON BIOMEDITECH CORP. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI 29dd36b3-fd00-4dc2-bc39-3b8f34811680 36 fields · synced May 30, 2026