Procleix System Fluid Preservative

GUDID 00859882007412

A buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Buffered sample diluent IVD, automated/semi-automated system

• Primary Device ID: 00859882007412
• NIH Device Record Key: f679a8ed-3251-4234-b28d-ca098b7296ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix System Fluid Preservative
• Version Model Number: Procleix System Fluid Preservative 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	00859882007412 [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

Devices Manufactured by GRIFOLS DIAGNOSTIC SOLUTIONS INC.

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• 00850032683050 - Procleix Babesia/WNV Quality Control: 2023-02-23 Procleix Babesia/WNV Quality Control, a set of quality controls, is intended for use as an external assayed quality control mate
• 00850032683067 - Procleix Babesia/WNV Quality Control: 2023-02-23 Procleix Babesia/WNV Quality Control, a set of quality controls, is intended for use as an external assayed quality control mate