APO B LP2117

GUDID 05055273204346

An APO B test system is a device intended for the quantitative in vitro determination of Apolipoprotein B (APO B) in serum and plasma.

RANDOX LABORATORIES LIMITED

Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Primary Device ID05055273204346
NIH Device Record Keye139e03a-ad01-48ff-8ac8-c4883b370f4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPO B
Version Model NumberLP2117
Catalog NumberLP2117
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

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273204346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JHNTurbidimetric Method, Lipoproteins

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 Date2016-09-26

On-Brand Devices [APO B]

05055273204469An APO B test system is a device intended for the quantitative in vitro determination of Apolipo
05055273204407An APO B test system is a device intended for the quantitative in vitro determination of Apolipo
05055273204377Immunoturbidimetric assay for the quantitative in vitro determination of Apolipoprotein B in hum
05055273204346An APO B test system is a device intended for the quantitative in vitro determination of Apolipo

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