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 ID08058056680617
NIH Device Record Keye952378d-9a0d-4725-8813-bb4bb4350579
Commercial Distribution StatusIn Commercial Distribution
Brand NameLipase Color Liquid
Version Model Number17401B
Catalog Number17401B
Company DUNS429572365
Company NameSENTINEL CH. SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it

Device Dimensions

Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter
Total Volume49 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108058056680617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CHILipase-Esterase, Enzymatic, Photometric, Lipase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-07-06
Device Publish Date2017-01-16

Devices Manufactured by SENTINEL CH. SPA

08058056680211 - Lp(a) Ultra2024-03-25 The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprote
08058056680228 - Lp(a) Cal Set2024-03-25 Lp(a) Cal Set should be used as calibration curve for the Lp(a) Ultra test. Use the Calibrator according to the indicated analyt
08058056681744 - Lp(a) Control Set2024-03-25 Lp(a) Control Set must only be used to verify the performance of the Lp(a) test. Use the Control material like the specimens, ac
08058056680181 - Ammonia Ultra 2023-11-30 The Ammonia Ultra assay is intended for the in vitro quantitative enzymatic determination of ammonia in human plasma using an au
08058056680617 - Lipase Color Liquid2023-07-06The 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.
08058056680617 - Lipase Color Liquid2023-07-06 The Lipase Color Liquid is an In Vitro Diagnostic test used for the determination of the lipase activity in serum and plasma by
08058056681911 - CRP Ultra (MP)2022-06-10 Latex immunoassay for the determination of the C-Reactive Protein (CRP) concentration in serum and plasma on VITROS® 4600 Chemi
08058056680136 - Clin Chem Cal2020-12-21 Clin Chem Cal must be used only for the calibration of clinical chemistry tests. For in vitro diagnostic use only.
08058056680099 - Clin Chem Control 12020-03-26 Clin Chem Control 1 is for use in quality control by monitoring accuracy and precision for the quantitative method as specified

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.