Procleix Panther Lower Bay Fluids

GUDID 00859882007610

A collection of reagents and other associated materials intended to be used to optimize an assay performed using a nucleic acid technique (NAT) on a clinical specimen.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

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

• Primary Device ID: 00859882007610
• NIH Device Record Key: 9cc7a50e-0523-4bfa-99c2-fae5670125cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Panther Lower Bay Fluids
• Version Model Number: Procleix Assay Fluids
• 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	00859882007610 [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 Panther Lower Bay Fluids]

• 00859882007627: A collection of reagents and other associated materials intended to be used to optimize an assay
• 00859882007610: A collection of reagents and other associated materials intended to be used to optimize an assay