ABX PENTRA HDL DIRECT CP

GUDID 03610230004999

HORIBA ABX SAS

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• Primary Device ID: 03610230004999
• NIH Device Record Key: 97bc31cb-2d3c-4e8e-838e-f2a4c78c28b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABX PENTRA HDL DIRECT CP
• Version Model Number: 1220001636
• Company DUNS: 273647420
• Company Name: HORIBA ABX SAS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610230004999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060854

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: 4
• Public Version Date: 2023-07-06
• Device Publish Date: 2016-09-17

Devices Manufactured by HORIBA ABX SAS

• 03610230004890 - ABX PENTRA ALP CP: 2023-07-06
• 03610230004913 - ABX PENTRA AMYLASE CP: 2023-07-06
• 03610230004920 - ABX PENTRA AST CP: 2023-07-06
• 03610230004937 - ABX PENTRA GGT CP: 2023-07-06
• 03610230004944 - ABX PENTRA LIPASE CP: 2023-07-06
• 03610230004975 - ABX PENTRA CHOLESTEROL CP: 2023-07-06
• 03610230004982 - ABX PENTRA BILIRUBIN, DIRECT CP: 2023-07-06
• 03610230004999 - ABX PENTRA HDL DIRECT CP: 2023-07-06
• 03610230004999 - ABX PENTRA HDL DIRECT CP: 2023-07-06