AccessGUDID - DEVICE: ACE Reagent (08058056685308)

GUDID

Device Identifier (DI) Information

Brand Name: ACE Reagent
Version or Model: 06U8225
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06U8225
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056685308
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin converting enzyme (ACE) activity in human serum or plasma on the ARCHITECT c System.This test is used as an aid in the diagnosis of pulmonary sarcoidosis and other pathologic conditions involving lung and liver diseases. For laboratory professional use only.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52945	Angiotensin converting enzyme (ACE) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of angiotensin converting enzyme (ACE) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQN	Radioassay, Angiotensin Converting Enzyme

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store between 2 and 8 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 683ea787-f828-4a24-8b43-c1da820b8744
Public Version Date: February 04, 2025
Public Version Number: 1
DI Record Publish Date: January 27, 2025