← Back to catalogue

Procleix WNV Assay

FDA UDI

by Grifols Diagnostic Solutions Inc.

Identity

Trade Name
Procleix WNV Assay FDA UDI
Generic Name
West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in human plasma and serum. FDA UDI
Model / Reference
1K Kit Box 2 FDA UDI
Description
The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in human plasma and serum. FDA UDI

Identifiers

Primary DI / UDI-DI
00850032683524 FDA UDI
GMDN Term
West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

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

Yes

FDA UDI

Category: West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix WNV Assay by Grifols Diagnostic Solutions Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Grifols Diagnostic Solutions Inc.

Sources (1)

  • FDA UDI eb4128a5-404e-47a6-9199-fdc7398b8ea3 33 fields · synced Jun 9, 2026