ACE Calibrator 06U8201

GUDID 08058056685285

ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin converting enzyme (ACE) assay on ARCHITECT c System. Use the CALIBRATOR according to the indicated analytical procedure. For In Vitro Diagnostic use. For laboratory professional use only.

SENTINEL CH. SPA

Angiotensin converting enzyme (ACE) IVD, calibrator

• Primary Device ID: 08058056685285
• NIH Device Record Key: 9400979f-99e0-4d6d-b1f9-bc0bd326b92b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE Calibrator
• Version Model Number: 06U8201
• Catalog Number: 06U8201
• 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	08058056685285 [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: 2025-02-04
• Device Publish Date: 2025-01-27

On-Brand Devices [ACE Calibrator]

• 08058056685315: ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin conver
• 08058056685285: ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin conver