HDL Cholesterol Precipitating Reagent 0599-020

GUDID 00657498000663

For Use in the Determination of High Density Lipoprotein (HDL) Cholesterol in Serum or Plasma.

STANBIO LABORATORY, L.P.

High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent

• Primary Device ID: 00657498000663
• NIH Device Record Key: 5eabf887-84e7-4fbb-a181-0f8aa34793b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HDL Cholesterol Precipitating Reagent
• Version Model Number: 0599-020
• Catalog Number: 0599-020
• 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	00657498000663 [Primary]

FDA Product Code

• LBR: Ldl & Vldl Precipitation, Hdl

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: 2018-03-29
• Device Publish Date: 2016-09-23

Devices Manufactured by STANBIO LABORATORY, L.P.

• 00657498002094 - Uri-Trak 120 M Urine Analyzer: 2023-06-16 The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for th
• 00657498002322 - HGB Controls - Low: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002339 - HGB Controls - Low: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002346 - HGB Controls - Normal: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002353 - HGB Controls - Normal: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002360 - HGB Controls - High: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002377 - HGB Controls - High: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498001806 - Standard 1: 2020-03-02 To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Sy