Lp(a) Ultra 11504D

GUDID 08058056680211

The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. For In Vitro Diagnostic use.

SENTINEL CH. SPA

Lipoprotein A IVD, reagent
Primary Device ID08058056680211
NIH Device Record Key426f19a1-c2a2-47c2-b269-303b81dfaf5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLp(a) Ultra
Version Model Number11504D
Catalog Number11504D
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
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it

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
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
GS108058056680211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DFCLipoprotein, Low-Density, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-25
Device Publish Date2024-03-15

Devices Manufactured by SENTINEL CH. SPA

08058056680211 - Lp(a) Ultra2024-03-25The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. For In Vitro Diagnostic use.
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 Liquid2023-07-06 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
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