Identity
- Trade Name
- Simplexa™ Flu A/B & RSV FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- MOL2600 FDA UDI
Identifiers
- Catalog Number
- MOL2600 FDA UDI
- Primary DI / UDI-DI
- 20816101025538 FDA UDI
- FDA Product Code
- OCC 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 UDI
- Commercial Distribution
- 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
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 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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- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay — LIFE TECHNOLOGIES LIMITED · Class II
- Lyra — DIAGNOSTIC HYBRIDS, INC. · Class II
- 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 6527cf96-d1d8-4d03-96df-b51ecde3821e 35 fields · synced Jun 9, 2026