LIPOPROTEIN (a) (Lp (a))

GUDID 05055273215861

RANDOX LABORATORIES LIMITED

Lipoprotein A IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 05055273215861
• NIH Device Record Key: 025ef282-f81e-4e02-9018-52416bce39bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIPOPROTEIN (a) (Lp (a))
• Version Model Number: LP8054
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273215861 [Primary]

FDA Product Code

• MSM: System, Test, Lipoprotein(A)

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: 2019-06-11
• Device Publish Date: 2019-06-03

On-Brand Devices [LIPOPROTEIN (a) (Lp (a))]

• 05055273215861: LP8054
• 05055273209235: LP8324