Dipper POCT Level 1&2 Set 20x1.5mL

Basic Information

• Brand Name: Dipper POCT Level 1&2 Set 20x1.5mL
• Primary DI: 00896863002387
• Version / Model: 1400-02
• Catalog Number: 1400-02
• 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: 2edeadc8-0541-4d60-a5ae-c520b0de381c

Device Description

The Dipper POCT is a two level urinalysis dipstick control. Each level is contained in a single-use plastic pouch filled with 1.5mL of liquid control material that is ready-to-use, requiring no reconstitution of dilution. The controls are formulated from a simulated urine matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated to target levels with compounds that produce the desired reaction when tested by methods indicated in the product insert.

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
JJW	Urinalysis Controls (Assayed And Unassayed)	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	00896863002387	GS1
Secondary	M0511400021	HIBCC

Customer Contacts

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

Storage Conditions

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