Identity
- Trade Name
- ACCURUN® 365 Series 200 FDA UDI
- Generic Name
- West Nile virus nucleic acid IVD, control FDA UDI
- Device Name
- ACCURUN® 365 Series 200 West Nile Virus Positive Control 10 x 1.5 mL per vial. FDA UDI
- Model / Reference
- 2020-0107 FDA UDI
- Description
- ACCURUN® 365 Series 200 West Nile Virus Positive Control 10 x 1.5 mL per vial. FDA UDI
Identifiers
- Catalog Number
- 2020-0107 FDA UDI
- Primary DI / UDI-DI
- 00816784020901 FDA UDI
- FDA Product Code
- MYZ FDA UDI
- GMDN Term
- West Nile virus nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II 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
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: West Nile virus nucleic acid IVD, control
ACCURUN® 365 Series 200 by LGC Clinical Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as West Nile virus nucleic acid IVD, control.
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
- LGC Clinical Diagnostics, Inc.
Sources (1)
- FDA UDI fb29cb44-16c2-4e15-a426-4af96d52c9b4 36 fields · synced Jun 9, 2026