DIRECT HDL-CHOLESTEROL (HDL)

GUDID 05055273208467

RANDOX LABORATORIES LIMITED

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• Primary Device ID: 05055273208467
• NIH Device Record Key: 1540e005-fe0c-46a9-b1a4-927cb0c3c624
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECT HDL-CHOLESTEROL (HDL)
• Version Model Number: CH8033
• 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	05055273208467 [Primary]

FDA Product Code

• LBS: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

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 [DIRECT HDL-CHOLESTEROL (HDL)]

• 05055273208467: CH8033
• 05055273208481: For the quantitative in vitro determination of HDL Cholesterol in serum and plasma.
• 05055273208412: Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in huma
• 05055273201185: Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in huma