AccessGUDID - DEVICE: ACE Liquid (08058056681751)

GUDID

Device Identifier (DI) Information

Brand Name: ACE Liquid
Version or Model: 1767001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1767001
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056681751
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: ACE Liquid reagent is for use in the determination of Angiotensin converting enzyme (ACE) activity in human serum or plasma. For In Vitro Diagnostic use.

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
Total Volume: 40 Milliliter

Device Record Status

Public Device Record Key: d23658f2-b274-4164-9f31-5427d91869b6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 29, 2016