Identity
- Trade Name
- Solana FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
- Device Name
- Solana RSV+hMPV Control Set FDA UDI
- Model / Reference
- M123 FDA UDI
- Description
- Solana RSV+hMPV Control Set FDA UDI
Identifiers
- Catalog Number
- M123 FDA UDI
- Primary DI / UDI-DI
- 30014613337003 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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: Multiple-genus respiratory virus nucleic acid IVD, control
Solana by Diagnostic Hybrids, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-genus respiratory virus nucleic acid IVD, control.
- Panther Fusion® — Hologic, Inc. · Class II
- Alinity m — Abbott Molecular · Class II
- Exact Diagnostics — Exact Diagnostics · Class I
- ACCURUN® — LGC Clinical Diagnostics, Inc.
- Simplexa™ Flu A/B & RSV Positive Control Pack — DiaSorin Molecular LLC · Class II
- Panther Fusion® — Hologic, Inc. · Class II
- NATtrol™ — ZeptoMetrix LLC · Class I
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · 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 | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostic Hybrids, Inc.
Sources (1)
- FDA UDI 92e4e11f-1192-4f57-80cd-415283d7e342 35 fields · synced Jun 8, 2026