Clinitek Atlas® Calibration Kit

Basic Information

• Brand Name: Clinitek Atlas® Calibration Kit
• Primary DI: 00630414373027
• Version / Model: 10311123
• Catalog Number: 5018A
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-11-19
• Public Version Status: Update
• Public Device Record Key: f805bd9f-571a-4c23-b8f4-8f65affbe17e

Device Description

Clinitek Atlas® Calibration Kit. For use with CLINITEK ATLAS® Automated Urine Chemistry System.

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
KQO	AUTOMATED URINALYSIS SYSTEM	Clinical Chemistry	862.2900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30219	Multiple urine analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414373027	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K932674	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not freeze
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius