LIAISON MeMed BV Control Set

GUDID 08056771602976

The DiaSorin LIAISON MeMed BV Control Set is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® MeMed BV assay.

Diasorin Inc.

Multiple cell-mediated host immune response marker IVD, control

• Primary Device ID: 08056771602976
• NIH Device Record Key: 3dde84b2-f9a6-40c1-9773-121bf01523bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIAISON MeMed BV Control Set
• Version Model Number: 318471
• Company DUNS: 033429783
• Company Name: Diasorin 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056771602976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213936

FDA Product Code

• QCH: Assayed Quality Control Material For Clinical Microbiology Assays

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: 2022-08-18
• Device Publish Date: 2022-08-10

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