Procleix Babesia Assay

GUDID 00859882007733

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.

Babesia microti nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00859882007733
• NIH Device Record Key: 646fd713-ce1f-471b-8f88-bbc29625fe16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Babesia Assay
• Version Model Number: Box 3
• 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	00859882007733 [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

On-Brand Devices [Procleix Babesia Assay]

• 00859882007740: The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det
• 00859882007733: The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det
• 00859882007726: The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det
• 00859882007719: The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det