Identity
- Trade Name
- PathoDX Respiratory Viral Panel FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- R62400 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080501680 FDA UDI
- 510(k) Number
- K983336 FDA UDI
- FDA Product Code
- LKT FDA UDI
- GMDN Term
- Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3480 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
No
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
Category: Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
PathoDX Respiratory Viral Panel by Remel Europe Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K983336 also covers:
- PathoDX Adenovirus Reagent — REMEL EUROPE LIMITED
- PathoDX Influenza A Reagent — REMEL EUROPE LIMITED
- PathoDX Influenza B Reagent — REMEL EUROPE LIMITED
- PathoDX RSV Reagent — REMEL EUROPE LIMITED
- PathoDX RVP Control Slides — REMEL EUROPE LIMITED
- PathoDX Respiratory Mounting Fluid — REMEL EUROPE LIMITED
- PathoDx Parainfluenza 1 Reagent — REMEL EUROPE LIMITED
- PathoDx Parainfluenza 2 Reagent — REMEL EUROPE LIMITED
- PathoDx Parainfluenza 3 Reagent — REMEL EUROPE LIMITED
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
- Remel Europe Limited
Sources (1)
- FDA UDI a96cdbbe-18bb-4468-b966-b0defc7c32bd 34 fields · synced May 30, 2026