Cholestech LDX™ 14874MR

GUDID 00810039380512

Cholestech LDX™ Analyzer

ALERE SAN DIEGO, INC.

Photometric/spectroscopic immunoassay analyser IVD
Primary Device ID00810039380512
NIH Device Record Key7a315590-c94b-4a86-96bd-f7a889ce854e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCholestech LDX™
Version Model Number14874
Catalog Number14874MR
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com
Phone+18774417440
EmailUSproductsupport@abbott.com

Operating and Storage Conditions

Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100810039380512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJFAnalyzer, Chemistry, Micro, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-28
Device Publish Date2023-12-20

On-Brand Devices [Cholestech LDX™]

00893038002036Cholestech LDX™ Multianalyte Controls (2 X 250µL)
00893038002029Cholestech LDX™ Multianalyte Calibration Verification
00893038002012Cholestech LDX™ Multianalyte Controls (2 X 2ml)
00893038002944Cholestech LDX™ Optics Check Cassette
00893038002937Cholestech LDX™ Lipid Profile GLU
00893038002920Alere Cholestech LDX™ TC HDL GLU
00893038002913Cholestech LDX™ Lipid Profile
00893038002906Cholestech LDX™ TC GLU
00893038002890Cholestech LDX™ TC HDL
00893038002883Cholestech LDX™ TC
00810039380512Cholestech LDX™ Analyzer
00810039380307Cholestech LDX™ Analyzer

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