Chromascopics Control Level 1&2 Set 4x120mL (Domestic) 1540-02

GUDID 00896863002042

The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus Automated Urine Chemistry Analyzer. It is also compatible with Siemens urinalysis dipsticks and Clinitek analyzers, confirmatory tests, and qualitative methods. It may also be used as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment. It is supplied as a liquid, ready-to-use control in two levels, configured with 2x120mL of each level per box. It does not required reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, non-pathogenic bacteria, and other compounds have been added to produce desired reactions when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth.

QUANTIMETRIX CORPORATION

Urine sediment IVD, control

• Primary Device ID: 00896863002042
• NIH Device Record Key: 2f601081-1643-4b74-9bd4-7ecd90bd5b03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chromascopics Control Level 1&2 Set 4x120mL (Domestic)
• Version Model Number: 1540-02
• Catalog Number: 1540-02
• Company DUNS: 010717890
• Company Name: QUANTIMETRIX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (310) 536-0006
• Email: sales@quantimetrix.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896863002042 [Primary]
HIBCC	M0511540021 [Secondary]

FDA Product Code

• JJW: Urinalysis Controls (Assayed And Unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-10
• Device Publish Date: 2018-09-26

Devices Manufactured by QUANTIMETRIX CORPORATION

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