Procleix WNV Assay

GUDID 00850032683548

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.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

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

• Primary Device ID: 00850032683548
• NIH Device Record Key: f4444936-2b31-4c58-8187-a97355d89e6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix WNV Assay
• Version Model Number: Calibrators Kit (15 Sets)
• Company DUNS: 056570085
• Company Name: GRIFOLS DIAGNOSTIC SOLUTIONS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850032683548 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-21
• Device Publish Date: 2025-08-13

On-Brand Devices [Procleix WNV Assay]

• 00859882007054: The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
• 00859882007047: The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
• 00859882007030: The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
• 00859882007023: The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
• 00859882007016: The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
• 00859882007009: The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
• 00850032683548: The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
• 00850032683531: The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
• 00850032683524: The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
• 00850032683517: The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of