Alere Cholestech LDX® 88769

GUDID 00893038002210

Alere Cholestech LDX® Multianalyte Controls (2 X 2ml)

ALERE SAN DIEGO, INC.

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device ID00893038002210
NIH Device Record Key973dfba9-91b8-4a83-b555-f66a546c3ebe
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlere Cholestech LDX®
Version Model Number88769
Catalog Number88769
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 Usefalse
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
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
Phone+18773088289
EmailUSproductsupport@alere.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100893038002210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-25
Device Publish Date2018-03-30

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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