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

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