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Idylla™ Respiratory (IFV-RSV) Panel
FDA UDIClass II (US FDA UDI)
by Biocartis NV
Identity
- Trade Name
- Idylla™ Respiratory (IFV-RSV) Panel FDA UDI
- Generic Name
- Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 1.0 FDA UDI
Identifiers
- Catalog Number
- A1030/6 FDA UDI
- Primary DI / UDI-DI
- 15415219000635 FDA UDI
- FDA Product Code
- OCC FDA UDI
- GMDN Term
- Multiple-type respiratory pathogen 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
- Not 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
No
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
Idylla™ Respiratory (IFV-RSV) Panel by Biocartis NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Biocartis NV
Sources (1)
- FDA UDI 8e599c39-0e75-4adb-8dfb-38bf47bc727a 34 fields · synced Jun 1, 2026