Identity
- Trade Name
- Procleix WNV/Babesia Quality Control FDA UDI
- Generic Name
- Multiple Babesia species nucleic acid IVD, control FDA UDI
- Device Name
- Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System. FDA UDI
- Model / Reference
- Babesia Positive Control FDA UDI
- Description
- Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850032683050 FDA UDI
- FDA Product Code
- QTM FDA UDI
- GMDN Term
- Multiple Babesia species nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3920 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
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 Babesia species nucleic acid IVD, control
Procleix WNV/Babesia Quality Control by Grifols Diagnostic Solutions Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple Babesia species nucleic acid IVD, control.
Cleared under the same submission
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
- Grifols Diagnostic Solutions Inc.
Sources (1)
- FDA UDI f123b2f2-bd36-494e-8c8d-e65ddb66b6bb 35 fields · synced Jun 9, 2026