Alinity c ACE Assay File 06U86-1A

GUDID 08058056685445

The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware.

SENTINEL CH. SPA

Laboratory instrument/analyser application software IVD

• Primary Device ID: 08058056685445
• NIH Device Record Key: 7f6ab125-2ab0-4e74-a76b-b8c002423043
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alinity c ACE Assay File
• Version Model Number: 06U86-1A
• Catalog Number: 06U86-1A
• Company DUNS: 429572365
• Company Name: SENTINEL CH. SPA
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058056685445 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-18
• Device Publish Date: 2025-03-10

Devices Manufactured by SENTINEL CH. SPA

• 08058056685438 - ARCHITECT c ACE Assay File: 2025-03-18 The ARCHITECT c ACE Assay File is an accessory intended to be used for driving and influencing the use of the ARCHITECT c system
• 08058056685445 - Alinity c ACE Assay File: 2025-03-18The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware.
• 08058056685445 - Alinity c ACE Assay File: 2025-03-18 The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system aut
• 08058056685285 - ACE Calibrator: 2025-02-04 ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin converting enzyme (ACE) assay on ARCHI
• 08058056685292 - ACE Control: 2025-02-04 ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the kinetic determination of angiot
• 08058056685308 - ACE Reagent: 2025-02-04 The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin conv
• 08058056685315 - ACE Calibrator: 2025-02-04 ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin converting enzyme (ACE) assay on Alini
• 08058056685322 - ACE Control: 2025-02-04 ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the kinetic determination of angiot
• 08058056685339 - ACE Reagent: 2025-02-04 The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin conv