ABX PENTRA PHOSPHORUS CP

GUDID 03610230005194

HORIBA ABX SAS

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• Primary Device ID: 03610230005194
• NIH Device Record Key: 7b5bbbd3-2ff6-4919-8947-8de9051e2bb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABX PENTRA PHOSPHORUS CP
• Version Model Number: 1220001665
• 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	03610230005194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070249

FDA Product Code

• CEO: Phosphomolybdate (Colorimetric), Inorganic Phosphorus

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: 2016-08-23

Devices Manufactured by HORIBA ABX SAS

• 03610230005392 - ABX PENTRA HBA1C WB: 2024-07-16
• 03610230005408 - ABX PENTRA HBA1C WB CAL: 2024-07-16
• 03610230005415 - ABX PENTRA HBA1C WB CONTROL: 2024-07-16
• 03610230005460 - ABX PENTRA HBA1C WB HEMOLYSIS REAGENT: 2024-07-16
• 03610230008157 - NUCEDIFF (1L): 2024-06-07
• 03610230008508 - Yumizen SPS: 2024-06-07
• 03610230008928 - Yumizen T6000: 2024-06-07 Right module SPS only
• 03610230008935 - Yumizen T6000: 2024-06-07 Right module Inst only