ACE Control 06U8210

GUDID 08058056685292

ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma on ARCHITECT c System. Use the Control material according to the indicated analytical procedure. For In Vitro Diagnostic use. For laboratory professional use only

SENTINEL CH. SPA

Angiotensin converting enzyme (ACE) IVD, control

• Primary Device ID: 08058056685292
• NIH Device Record Key: 4ee6cdf3-5e3d-40b4-aa7b-1044273f6773
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE Control
• Version Model Number: 06U8210
• Catalog Number: 06U8210
• 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: 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

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058056685292 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2025-02-04
• Device Publish Date: 2025-01-27

On-Brand Devices [ACE Control]

• 08058056685322: ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the
• 08058056685292: ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the