Procleix Zika Virus Assay

GUDID 00859882007504

The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the detection of Zika virus (ZIKV) RNA in plasma and serum specimens from human donors.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Zika virus nucleic acid IVD, calibrator

• Primary Device ID: 00859882007504
• NIH Device Record Key: 551a350e-0adf-45cb-8b07-276d0a5212ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Zika Virus Assay
• Version Model Number: 5K Calibrators
• 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	00859882007504 [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: 2019-03-11
• Device Publish Date: 2019-02-27

On-Brand Devices [Procleix Zika Virus Assay]

• 00859882007658: The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the
• 00859882007641: The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the
• 00859882007634: The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the
• 00859882007504: The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the
• 00859882007481: The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the
• 00859882007474: The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the
• 00859882007467: The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the
• 00859882007450: The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the