Identity
- Trade Name
- PathoDX Respiratory Mounting Fluid FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, reagent FDA UDI
- Model / Reference
- R62413 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080501765 FDA UDI
- 510(k) Number
- K983336 FDA UDI
- FDA Product Code
- LKT FDA UDI
- GMDN Term
- Multiple-genus respiratory virus antigen IVD, reagent 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, reagent
PathoDX Respiratory Mounting Fluid by Remel Europe Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-genus respiratory virus antigen IVD, reagent.
- PathoDX Influenza B Reagent — REMEL EUROPE LIMITED · Class I
- PathoDX Influenza A Reagent — REMEL EUROPE LIMITED · Class I
- PathoDx Parainfluenza 2 Reagent — REMEL EUROPE LIMITED · Class I
- PathoDX RSV Reagent — REMEL EUROPE LIMITED · Class I
- PathoDX Adenovirus Reagent — REMEL EUROPE LIMITED · Class I
- PathoDx Parainfluenza 1 Reagent — REMEL EUROPE LIMITED · Class I
- PathoDx Parainfluenza 3 Reagent — REMEL EUROPE LIMITED · Class I
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 Viral Panel — 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 |
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Manufacturer
- Manufacturer
- Remel Europe Limited
Sources (1)
- FDA UDI 5329a93e-0a23-4a94-8308-9e7ffde45a1e 34 fields · synced Jun 1, 2026