SAMPLE CUP - BLUE

GUDID 03610230006702

HORIBA ABX SAS

General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium

• Primary Device ID: 03610230006702
• NIH Device Record Key: f599348f-3dd5-4c08-95e1-dcc56c665023
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAMPLE CUP - BLUE
• Version Model Number: 1220001765
• Company DUNS: 273647420
• Company Name: HORIBA ABX SAS
• Device Count: 1000
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610230006702 [Primary]
GS1	03610230008133 [Unit of Use]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2021-01-22
• Device Publish Date: 2016-09-20

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