Alinity c Acetaminophen Calibrator

GUDID 00628063401321

SEKISUI DIAGNOSTICS, LLC

Acetaminophen IVD, calibrator

• Primary Device ID: 00628063401321
• NIH Device Record Key: 433e98dc-6512-4eab-9647-496c49a56361
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alinity c Acetaminophen Calibrator
• Version Model Number: 07P5401
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628063401321 [Primary]

FDA Product Code

• JIT: Calibrator, Secondary

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: 2023-05-16
• Device Publish Date: 2023-05-08

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
• 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