AccessGUDID - DEVICE: POINTE SCIENTIFIC Ammonia Standard 5 (00811727010278)

GUDID

Device Identifier (DI) Information

Brand Name: POINTE SCIENTIFIC Ammonia Standard 5
Version or Model: A7553-STD500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A7553-STD500
Company Name: HORIBA INSTRUMENTS INCORPORATED

Primary DI Number: 00811727010278
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052845583 *Terms of Use

Device Description: The Ammonia Standards are intended for the calibration of ammonia assays.

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?
53206	Ammonia 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 ammonia in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIF	Enzymatic Method, Ammonia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K864706	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a4243ae-0126-418d-b3d1-37546009459c
Public Version Date: October 02, 2025
Public Version Number: 4
DI Record Publish Date: August 31, 2016