HDL CH3811

GUDID 05055273201291

An HDL-cholesterol test system is a device intended for the quantitative in vitro determination of HDL-cholesterol concentration in human serum and pl

RANDOX LABORATORIES LIMITED

High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry
Primary Device ID05055273201291
NIH Device Record Key8271acf4-c007-4533-8206-4b3d140c69aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameHDL
Version Model NumberCH3811
Catalog NumberCH3811
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
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273201291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-24
Device Publish Date2018-12-24

Devices Manufactured by RANDOX LABORATORIES LIMITED

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