AccessGUDID - DEVICE: Ammonia Ultra (08058056680181)

GUDID

Device Identifier (DI) Information

Brand Name: Ammonia Ultra
Version or Model: 17660
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17660
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056680181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: The Ammonia Ultra assay is intended for the in vitro quantitative enzymatic determination of ammonia in human plasma using an automated analyzer. Measurements of ammonia are used to aid in the diagnosis of patients suspected of having hyperammonemia. 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?
53205	Ammonia IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ammonia in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIF	Enzymatic Method, Ammonia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051114	000

Device Exempt from Premarket Submission: No 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: dbb56e7d-4ebd-4a9f-ab74-aa7cd77f75cf
Public Version Date: November 30, 2023
Public Version Number: 1
DI Record Publish Date: November 22, 2023