Procleix Tigris Lower Bay Fluids

Basic Information

• Brand Name: Procleix Tigris Lower Bay Fluids
• Primary DI: 00859882007399
• Version / Model: Procleix Buffer for Deactivation Fluid Kit
• Company Name: GRIFOLS DIAGNOSTIC SOLUTIONS INC.
• Labeler DUNS: 056570085
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-03
• Public Version: 1
• Public Version Date: 2018-09-03
• Public Version Status: New
• Public Device Record Key: 988a2d6a-7752-4f5d-8a82-4b5259d45c91

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
61194	Nucleic acid technique (NAT) kit IVD	A collection of reagents and other associated materials intended to be used to optimise an assay performed using a nucleic acid technique (NAT) on a clinical specimen. The kit typically consists of a silicone oil to minimize evaporation, buffered solutions for washing steps and reaction stop reagents.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859882007399	GS1