Cholesterol Standard (200 mg/dL) 1012-030

GUDID 00657498001141

Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Plasma.

STANBIO LABORATORY, L.P.

Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent

• Primary Device ID: 00657498001141
• NIH Device Record Key: ef848634-9bbb-48ce-8b22-b45c40e0c9a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cholesterol Standard (200 mg/dL)
• Version Model Number: 1012-030
• Catalog Number: 1012-030
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• 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: 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

Customer Support Contacts

• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498001141 [Primary]

FDA Product Code

• CHH: Enzymatic Esterase--Oxidase, Cholesterol

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-16
• Device Publish Date: 2016-09-23

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