Yumizen C1200 Calcium AS

GUDID 03610230008607

HORIBA ABX SAS

Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry

• Primary Device ID: 03610230008607
• NIH Device Record Key: fc4eefbf-d30f-42d2-bb3d-1607d9b6e654
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yumizen C1200 Calcium AS
• Version Model Number: 1300047910
• 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	03610230008607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191396

FDA Product Code

• CJY: Azo Dye, Calcium

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-14
• Device Publish Date: 2020-05-06

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