ABX PENTRA ALP CP

GUDID 03610230004890

HORIBA ABX SAS

Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry

• Primary Device ID: 03610230004890
• NIH Device Record Key: fff8d706-58d5-4941-b23a-f676a950a5d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABX PENTRA ALP CP
• Version Model Number: 1220001626
• 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	03610230004890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060205

FDA Product Code

• CJE: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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: 2016-05-02

Devices Manufactured by HORIBA ABX SAS

• 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
• 03610230008942 - Yumizen T6000: 2024-06-07 Right module 1 Inst back
• 03610230008959 - Yumizen T6000: 2024-06-07 Right module 2 Inst
• 03610230004890 - ABX PENTRA ALP CP: 2023-07-06
• 03610230004890 - ABX PENTRA ALP CP: 2023-07-06
• 03610230004913 - ABX PENTRA AMYLASE CP: 2023-07-06