Procleix HIV-1/HCV/HBV Quality Control

GUDID 00850032683029

Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control Hepatitis C virus nucleic acid IVD, control

• Primary Device ID: 00850032683029
• NIH Device Record Key: 7f02bef7-523e-41ca-9bb4-2ab787fb9aba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix HIV-1/HCV/HBV Quality Control
• Version Model Number: HCV Positive Control
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com
• Phone: 1-800-452-6877
• Email: service.americas@grifols.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850032683029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK220736

FDA Product Code

• QTM: Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

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: 2023-02-23
• Device Publish Date: 2023-02-15

On-Brand Devices [Procleix HIV-1/HCV/HBV Quality Control]

• 00850032683036: Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an e
• 00850032683029: Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an e
• 00850032683012: Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an e
• 00850032683005: Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an e