Procleix Parasite Transport Medium

GUDID 00859882007757

The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Blood cell lysis reagent IVD

• Primary Device ID: 00859882007757
• NIH Device Record Key: a328df11-2c11-4cb3-a705-9a064f4ba0e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Parasite Transport Medium
• Version Model Number: Lysis Buffer
• 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	00859882007757 [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: 2019-03-28
• Device Publish Date: 2019-03-20

Devices Manufactured by GRIFOLS DIAGNOSTIC SOLUTIONS INC.

• 00859882007948 - Procleix Xpress System: 2023-06-19 The Procleix Xpress System (Software and Instrument) is intended to be used to create pools of human plasma or serum for blood s
• 00850032683005 - Procleix HIV-1/HCV/HBV Quality Control: 2023-02-23 Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control
• 00850032683012 - Procleix HIV-1/HCV/HBV Quality Control: 2023-02-23 Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control
• 00850032683029 - Procleix HIV-1/HCV/HBV Quality Control: 2023-02-23 Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control
• 00850032683036 - Procleix HIV-1/HCV/HBV Quality Control: 2023-02-23 Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control
• 00850032683043 - 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
• 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