Alere Cholestech LDX® 99021

GUDID 00899722002344

Alere Cholestech LDX® Lipid Profile GLU

ALERE SAN DIEGO, INC.

Multiple lipid analyte IVD, reagent
Primary Device ID00899722002344
NIH Device Record Keyb749b3a7-ad57-45d4-9ac0-52fce11d4577
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlere Cholestech LDX®
Version Model Number99021
Catalog Number99021
Company DUNS194854949
Company NameALERE SAN DIEGO, INC.
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com
Phone+18773088289
EmailUSproductsupport@alere.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100899722002344 [Primary]

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-10-18
Device Publish Date2016-06-29

On-Brand Devices [Alere Cholestech LDX®]

00854361008003Alere Cholestech LDX® Analyzer
04571226470831Alere Cholestech LDX® Lipid Profile●GLU
00893038002845Alere Cholestech LDX® Multianalyte Controls
00893038002210Alere Cholestech LDX® Multianalyte Controls (2 X 2ml)
00899722002344Alere Cholestech LDX® Lipid Profile GLU
00893038002654Alere Cholestech LDX® Lipid Profile GLU
00893038002647Alere Cholestech LDX® TC HDL GLU
00893038002630Alere Cholestech LDX® Lipid Profile
00893038002623Alere Cholestech LDX® TC GLU
00893038002616Alere Cholestech LDX® TC HDL
00893038002609Alere Cholestech LDX® TC
00893038002524Alere Cholestech LDX® Optics Check Cassette

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