LIPID LINEARITY VERIFIERS (For Roche Systems) (LLV-R) LV10344

GUDID 05055273216257

Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Cholesterol, HDL, LDL and Triglycerides.

RANDOX LABORATORIES LIMITED

Multiple lipid analyte IVD, control

• Primary Device ID: 05055273216257
• NIH Device Record Key: 45a123f2-a12e-4376-b7f8-c706682652e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIPID LINEARITY VERIFIERS (For Roche Systems) (LLV-R)
• Version Model Number: LV10344
• Catalog Number: LV10344
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273216257 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-12-08
• Device Publish Date: 2019-08-01

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