UA-Cellular for IQ

Basic Information

• Brand Name: UA-Cellular for IQ
• Primary DI: 00844509001966
• Version / Model: 213396
• Catalog Number: 213396
• Company Name: STRECK, INC.
• Labeler DUNS: 072915986
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ab178264-2875-4a84-aaab-d03da1728300

Device Description

Urinalysis control designed specifically for the Iris Diagnostics iQ® automated urine analyzers. Contains 1 vial each of Level 1 & 2.

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: Yes
• 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
JPK	Mixture, Hematology Quality Control	Hematology	864.8625	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42065	Urine sediment IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844509001966	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090201	000

Device Sizes

Type	Value	Unit	Text
Total Volume	120	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius