Procleix WNV/Babesia Quality Control

FDA UDI

Class II (US FDA UDI)

by Grifols Diagnostic Solutions Inc.

Identity

Trade Name: Procleix WNV/Babesia Quality Control FDA UDI
Generic Name: West Nile virus 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: WNV 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: 00850032683067 FDA UDI
FDA Product Code: QTM FDA UDI
GMDN Term: West Nile virus 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: West Nile virus 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 West Nile virus nucleic acid IVD, control.

Cleared under the same submission

BK220746 also covers:

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 19edcbd5-1306-408e-b92d-70bea03862c4 35 fields · synced Jun 9, 2026