Procleix Ultrio Elite Assay

GUDID 00859882007580

The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00859882007580
• NIH Device Record Key: 319604d9-3e83-47fa-bec0-8792598ce9cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Ultrio Elite Assay
• Version Model Number: 5K Kit Box 4
• 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	00859882007580 [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 Ultrio Elite Assay ]

• 00859882007696: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007689: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007672: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007665: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007603: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007597: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007580: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007573: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007566: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007559: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007542: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007535: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th
• 00859882007528: The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for th