← Back to catalogue
Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence Assay
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence Assay FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- SimulFluor® Flu A/Flu B Immunofluorescence Assay FDA UDI
- Model / Reference
- 3121 FDA UDI
- Description
- SimulFluor® Flu A/Flu B Immunofluorescence Assay FDA UDI
Identifiers
- Catalog Number
- 3121 FDA UDI
- Primary DI / UDI-DI
- 04053252367588 FDA UDI
- 510(k) Number
- K974302 FDA UDI
- FDA Product Code
- GNW FDA UDI
- GMDN Term
- Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3330 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence Assay by Emd Millipore Corporation — Class I — FDA UDI — listed in FDA GUDID
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 | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Emd Millipore Corporation
Sources (1)
- FDA UDI 9c3d1120-1694-4f92-87d2-466a0370ee7c 38 fields · synced May 30, 2026