Atellica CH UA

Basic Information

• Brand Name: Atellica CH UA
• Primary DI: 00630414654133
• Version / Model: 11645765
• Catalog Number: 11645765
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2026-04-08
• Public Version: 1
• Public Version Date: 2026-04-16
• Public Version Status: New
• Public Device Record Key: b0439348-a6c8-43ea-8178-0e493062b22f

Device Description

Uric Acid (UA) Atellica CH - RGT 2400T

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
KNK	Acid, uric, uricase (colorimetric)	Clinical Chemistry	862.1775	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53583	Uric acid IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of uric acid in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00630414322162	GS1
Primary	00630414654133	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K991576	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius