Clin Chem Control 2 16250

GUDID 08058056680105

Clin Chem Control 2 is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table. Use the Control Material like the specimens, according to the indicated analytical procedure. For In Vitro Diagnostic use.

SENTINEL CH. SPA

Multiple clinical chemistry analyte IVD, control

• Primary Device ID: 08058056680105
• NIH Device Record Key: f68869c5-1f60-4721-8caa-1f874eae0de1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clin Chem Control 2
• Version Model Number: 16250
• Catalog Number: 16250
• Company DUNS: 429572365
• Company Name: SENTINEL CH. SPA
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it

Device Dimensions

• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058056680105 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2020-03-26
• Device Publish Date: 2020-03-18

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• 08058056685308 - ACE Reagent: 2025-02-04 The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin conv
• 08058056685315 - ACE Calibrator: 2025-02-04 ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin converting enzyme (ACE) assay on Alini
• 08058056685322 - ACE Control: 2025-02-04 ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the kinetic determination of angiot
• 08058056685339 - ACE Reagent: 2025-02-04 The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin conv
• 08058056680211 - Lp(a) Ultra: 2024-03-25 The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprote
• 08058056680228 - Lp(a) Cal Set: 2024-03-25 Lp(a) Cal Set should be used as calibration curve for the Lp(a) Ultra test. Use the Calibrator according to the indicated analyt