Chromascopics Control Level 1&2 Set 2x25mL (International) 1540-03

GUDID 00896863002424

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 2x25mL of each level per bag. 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: 00896863002424
• NIH Device Record Key: ce83790e-f1b8-4b69-a010-b0ecea57234a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chromascopics Control Level 1&2 Set 2x25mL (International)
• Version Model Number: 1540-03
• Catalog Number: 1540-03
• 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
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com
• Phone: (310) 536-0006
• Email: sales@quantimetrix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896863002424 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-12
• Device Publish Date: 2023-05-04

Devices Manufactured by QUANTIMETRIX CORPORATION

• 00896863002424 - Chromascopics Control Level 1&2 Set 2x25mL (International): 2023-05-12The 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 2x25mL of each level per bag. 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.
• 00896863002424 - Chromascopics Control Level 1&2 Set 2x25mL (International): 2023-05-12 The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus
• 00896863002356 - QuanTtest Human Protein Standards Set: 2021-09-20 QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay Sys
• 00896863002004 - Dropper Spinal Fluid Control Level 1 Set 3x3mL: 2020-12-21 The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of p
• 00896863002011 - Dropper Spinal Fluid Control Level 2 Set 3x3mL: 2020-12-21 The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of p
• 00896863002073 - Dropper Spinal Fluid Control Level 1&2 Set 2x3mL: 2020-12-21 The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of p
• 00896863002042 - Chromascopics Control Level 1&2 Set 4x120mL (Domestic): 2020-01-10 The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus
• M0515210120 - QuanTtest Red Pyrogallol Red Reagent: 2019-10-07 QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in a
• 00089686302042 - Chromascopics Control Level 1&2 Set 4x120mL (Domes: 2018-10-29 The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus