QuanTscopics Control Level 2 Set 4x120mL

Basic Information

• Brand Name: QuanTscopics Control Level 2 Set 4x120mL
• Primary DI: 00896863002271
• Version / Model: 1482-41
• Catalog Number: 1482-41
• Company Name: QUANTIMETRIX CORPORATION
• Labeler DUNS: 010717890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-26
• Public Version: 1
• Public Version Date: 2018-10-29
• Public Version Status: New
• Public Device Record Key: efd9e85c-3aa2-4f65-874f-c32ec382b4a6

Device Description

The QuanTscopics Urinalysis Microscopics Control is intended for use as quality control material for the microscopic evaluation of various urine sediment methods. It is supplied in two level, 4x120mL bottles per level per box. It is liquid, ready-to-use, requiring no reconstitution or dilution. The control is made from human urine to which stabilized human red blood cells, human white blood cells, and uric acid, calcium oxalate, and calcium phosphate crystals have been added.

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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

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
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	00896863002271	GS1
Secondary	M05114824114	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K925256	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius