Identity
- Trade Name
- Simplexa™ Flu A/B & RSV Direct Gen II FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- MOL2655 FDA UDI
Identifiers
- Catalog Number
- MOL2655 FDA UDI
- Primary DI / UDI-DI
- 20816101026962 FDA UDI
- 510(k) Number
- K201505 FDA UDI
- FDA Product Code
- OCC FDA UDIOOI FDA UDI
- GMDN Term
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3980 FDA UDI862.2570 FDA UDI
- 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
Yes
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
Category: Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Simplexa™ Flu A/B & RSV Direct Gen II by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT).
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- BD Respiratory Viral Panel for BD MAX™ System — BECTON DICKINSON AND COMPANY · Class II
- Alinity m — Abbott Molecular · N
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay — LIFE TECHNOLOGIES LIMITED · Class II
- Solana — DIAGNOSTIC HYBRIDS, INC. · Class II
- Alinity m — Abbott Molecular · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- DiaSorin Molecular LLC
Sources (1)
- FDA UDI 2091dd67-be65-4b71-8b11-22f81ace3c1e 36 fields · synced Jun 9, 2026