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

08058056685285 - ACE Calibrator2025-02-04 ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin converting enzyme (ACE) assay on ARCHI
08058056685292 - ACE Control2025-02-04 ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the kinetic determination of angiot
08058056685308 - ACE Reagent2025-02-04 The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin conv
08058056685315 - ACE Calibrator2025-02-04 ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin converting enzyme (ACE) assay on Alini
08058056685322 - ACE Control2025-02-04 ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the kinetic determination of angiot
08058056685339 - ACE Reagent2025-02-04 The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin conv
08058056680211 - Lp(a) 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
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