Procleix Syscheck

GUDID 00859882007405

A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. It may also include reference material to optimize and verify performance of the luminometer instrument.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD

• Primary Device ID: 00859882007405
• NIH Device Record Key: f6360d07-4df8-403c-962d-4f5f5c5a2177
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Syscheck
• Version Model Number: Instrument Verification Solution
• 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	00859882007405 [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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• 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