Lipase Color Liquid 17401B

GUDID 08058056680617

The Lipase Color Liquid is an In Vitro Diagnostic test used for the determination of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only.

SENTINEL CH. SPA

Lipase IVD, kit, spectrophotometry

• Primary Device ID: 08058056680617
• NIH Device Record Key: e952378d-9a0d-4725-8813-bb4bb4350579
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lipase Color Liquid
• Version Model Number: 17401B
• Catalog Number: 17401B
• Company DUNS: 429572365
• Company Name: SENTINEL CH. SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Device Dimensions

• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 Milliliter
• Total Volume: 49 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	08058056680617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961179

FDA Product Code

• CHI: Lipase-Esterase, Enzymatic, Photometric, Lipase

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-06
• Device Publish Date: 2017-01-16

Devices Manufactured by SENTINEL CH. SPA

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• 08058056685292 - 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
• 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