ACE Calibrator

Basic Information

• Brand Name: ACE Calibrator
• Primary DI: 08058056685285
• Version / Model: 06U8201
• Catalog Number: 06U8201
• Company Name: SENTINEL CH. SPA
• Labeler DUNS: 429572365
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-27
• Public Version: 1
• Public Version Date: 2025-02-04
• Public Version Status: New
• Public Device Record Key: 9400979f-99e0-4d6d-b1f9-bc0bd326b92b

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIT	Calibrator, Secondary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46015	Angiotensin converting enzyme (ACE) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of angiotensin converting enzyme (ACE) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08058056685285	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: : Store between 2 and 8 degrees Celsius