Lp (a) LP2757

GUDID 05055273209198

Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma.

RANDOX LABORATORIES LIMITED

Lipoprotein A IVD, kit, nephelometry/turbidimetry
Primary Device ID05055273209198
NIH Device Record Key156bdb7b-4adc-4d3a-8e23-5a09dd3ecb34
Commercial Distribution StatusIn Commercial Distribution
Brand NameLp (a)
Version Model NumberLP2757
Catalog NumberLP2757
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
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 Usetrue
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

Phone+442894451070
Emailtechnical.services@randox.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273209198 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [Lp (a)]

05055273209198Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human
05055273204421Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human
05055273204384For the quantitative in vitro determination of Lipoprotein (a) in human serum or plasma.

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