FDA.reportPublic FDA data

Cholestech LDX™

Primary DI
00893038002944
Brand
Cholestech LDX™
Company
Alere San Diego, Inc.
Model
10228
Catalog number
10228MR
Device description
Cholestech LDX™ Optics Check Cassette
Published
2023-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJTEnzyme Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJTEnzyme Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893038002944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893038002944008930380029448930380029440893038002944

GMDN Terms#

Term, Definition table
TermDefinition
Optical laboratory instrument performance standard calibrator/control IVD, reusableA solid phase or liquid reference standard of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader). It is typically presented as a solid/sealed cuvette or a multiple-well test plate and may include filters or a light source emitted at specified wavelengths. Verification/optimization functions may include optical density (absorbance/scattering), fluorescent or luminescent accuracy, linearity, repeatability and/or limit of detection readings, and optical alignment and precision of the instrument/analyser. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18774417440USproductsupport@abbott.com

Regulatory Flags#

DUNS number
194854949
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810124272975CERTUM One Step Multi-Line Drug Screen EZ SplitDBO-167-022-a45651613262024-10-10
00810124272982SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 300)DAM-A101-a-Sgl2023-12-15
00810124272999SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 1000)DAM-101-a-Sgl2023-12-15
00810124273002SureStepTM Urine Test Drug Screen Strip, Barbiturates (BAR 300)DBA-101-a-Sgl2023-12-15
00810124273019SureStepTM Urine Test Drug Screen Strip, Buprenorphine (BUP10)DBU-101-a-Sgl2023-12-15
00810124273026SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300)DBZ-101-a-Sgl2023-12-15
00810124273033SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 150)DCO-U101-a-Sgl2023-12-15
00810124273040SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 500)DME-U101-a-Sgl2023-12-15
00810124273057SureStepTM Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500DMD-101-a-Sgl2023-12-15
00810124273064SureStepTM Urine Test Drug Screen Strip, Opiate (MOP 300)DMO-101-a-Sgl2023-12-15
00810124273071SureStepTM Urine Test Drug Screen Strip, Methadone (MTD 300)DMT-101-a-Sgl2023-12-15
00810124273088SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)DTC-101-a-Sgl2023-12-15
00810124273095SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50)DTH-101-a-Sgl2023-12-15
00810124273149SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-157-01245653390192024-09-17
00810124273156SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-167-52145653490192024-09-17
00810124273163SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-1107-02145653590192024-09-17
00810124273170SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-1107-01145653690192024-09-17
00810124273200SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 300)DCO-101-a-Sgl2023-12-15
00810124273217SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000)DME-101-a-Sgl2023-12-15
00810124273224SureStepTM Urine Test Drug Screen Strip, Opiate (OPI 2000)DMO-101-a-Sgl2023-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740156381ARCHITECTABBOTT LABORATORIESJJT2020-03-03
00380740156398ARCHITECTABBOTT LABORATORIESJJT2020-03-03
04015630947119PreciControl ISDRoche Diagnostics GmbHJJT2019-01-14
04015630947126CalCheck ISDRoche Diagnostics GmbHJJT2019-01-14
00380740044831ARCHITECTABBOTT LABORATORIESJJT2018-07-31
00380740045593ARCHITECTABBOTT LABORATORIESJJT2018-07-31
00856743007024Cardiac Control MarkerMORE DIAGNOSTICS INCJJT2018-03-31
00856743007031Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-31
00856743007048Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-31
00893038002524Alere Cholestech LDX®Alere San Diego, Inc.JJT2018-03-30
00856743007017Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-30
M52551340CK/LD Isoenzyme Control (5 x 2 mL)HELENA LABORATORIES CORPORATIONJJT2017-03-17
00847661001225LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00847661001232LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00847661002154LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00852553007049Enzymer Verifier KitVERICHEM LABORATORIES, INC.JJT2016-11-29
00852553007056Enzymer ER Verifier KitVERICHEM LABORATORIES, INC.JJT2016-11-29
00852553007131Enzymer ER Verifier, Level GVERICHEM LABORATORIES, INC.JJT2016-11-29
00725609000205SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00725609000212SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00725609000441SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00725609000458SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00384840518902Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCJJT2016-09-22
00038481518505Prodigy AutoCode Blood Glucose Monitoring SystemPRODIGY DIABETES CARE, LLCJJT2016-09-22