AccessGUDID - DEVICE: Alinity c ACE Assay File (08058056685445)

GUDID

Device Identifier (DI) Information

Brand Name: Alinity c ACE Assay File
Version or Model: 06U86-1A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06U86-1A
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056685445
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: 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.

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:	No
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?
43472	Laboratory instrument/analyser application software IVD	An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7f6ab125-2ab0-4e74-a76b-b8c002423043
Public Version Date: March 18, 2025
Public Version Number: 1
DI Record Publish Date: March 10, 2025