Total Bilirubin SK284-20

GUDID 00628063400225

SEKISUI DIAGNOSTICS, LLC

Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry

• Primary Device ID: 00628063400225
• NIH Device Record Key: 528febc7-2207-46d6-a014-bccf481e205c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Bilirubin
• Version Model Number: SK284-20
• Catalog Number: SK284-20
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• 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: true
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628063400225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023330

FDA Product Code

• CIG: DIAZO COLORIMETRY, BILIRUBIN

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: 2018-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

• 00628063401291 - Acetaminophen: 2023-05-16
• 00628063401307 - Acetaminophen Calibrator: 2023-05-16
• 00628063401314 - Alinity c Acetaminophen: 2023-05-16
• 00628063401321 - Alinity c Acetaminophen Calibrator: 2023-05-16
• 10742860100397 - OSOM ULTRA PLUS FLU A&B Test: 2022-06-10
• 00628063401222 - DC-TROL LEVELS 1 & 2: 2020-04-07
• 00628063400003 - Carbon Dioxide L3K: 2019-10-21
• 00628063400287 - CARBON DIOXIDE L3K Assay: 2019-10-21