PENTRA C200 ISE

GUDID 03610230006672

HORIBA ABX SAS

Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory

• Primary Device ID: 03610230006672
• NIH Device Record Key: 915c9906-a451-43db-a32d-88bf99614c6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PENTRA C200 ISE
• Version Model Number: 1280090002
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	03610230006672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103788

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: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-02

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