Procleix Ultrio Plus Assay

GUDID 00859882007191

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

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

• Primary Device ID: 00859882007191
• NIH Device Record Key: cca77114-78f3-42c7-a826-55fe4d382609
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Ultrio Plus Assay
• Version Model Number: Calibrators 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859882007191 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-06

On-Brand Devices [Procleix Ultrio Plus Assay]

• 00859882007214: Negative Control Kit
• 00859882007207: Negative Calibrator Kit
• 00859882007191: Calibrators Kit
• 00859882007184: Controls Kit
• 00859882007177: HBV dprobe kit
• 00859882007160: HCV dprobe kit
• 00859882007153: HIV-1 dprobe kit
• 00859882007146: 5K Kit Box 5
• 00859882007139: 5K Kit Box 4
• 00859882007122: 5K Kit Box 3
• 00859882007115: 5K Kit Box 2
• 00859882007108: 5K Kit Box 1
• 00859882007092: 1K Kit Box 4
• 00859882007085: 1K Kit Box 3
• 00859882007078: 1K Kit Box 2
• 00859882007061: 1K Kit Box 1