Procleix Ultrio Assay

GUDID 00859882007313

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

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

• Primary Device ID: 00859882007313
• NIH Device Record Key: c10abc82-ce65-45c5-aaf4-a1723444bf30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Ultrio Assay
• Version Model Number: HBV Discriminatory Probe Reagent Kit
• 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	00859882007313 [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: 2018-09-03
• Device Publish Date: 2018-08-03

On-Brand Devices [Procleix Ultrio Assay]

• 00859882007351: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007344: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007337: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007320: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007313: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007306: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007290: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007283: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007276: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007269: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007252: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007245: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007238: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
• 00859882007221: The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection