Ammonia Standard

Basic Information

• Brand Name: Ammonia Standard
• Primary DI: 00817238011247
• Version / Model: R85406
• Company Name: CLINIQA CORPORATION
• Labeler DUNS: 078742335
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-23
• Public Version: 2
• Public Version Date: 2019-02-04
• Public Version Status: Update
• Public Device Record Key: 0af4d88f-7c82-4579-ab7e-f8626fea7cf8

Device Description

Ammonia Standard

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIF	Enzymatic Method, Ammonia	Clinical Chemistry	862.1065	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53207	Ammonia IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of ammonia in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817238011247	GS1