FDA.reportPublic FDA data

IDG/Sanzay

Primary DI
00850053916250
Brand
IDG/Sanzay
Company
IDG/SANZAY Corporation
Model
1
Catalog number
QS31D
Device description
The HDL-LDL calibrator is used to establish the value of high density lipoprotein cholesterol and low-density lipoprotein cholesterol for IDG HDL Cholesterol Enzymatic and LDL Cholesterol Enzymatic Assays, respectively. The calibrator isfor in vitro diagnostic use only.
Published
2024-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072395000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072395000DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLSDiazyme Laboratories2008-01-03LBS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053916250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053916250008500539162508500539162500850053916250

GMDN Terms#

Term, Definition table
TermDefinition
Multiple lipid analyte IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
948875013
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850053916212IDG/Sanzay1HCC12024-01-12
00850053916229IDG/Sanzay1HCC22024-01-12
00850053916007IDG/Sanzay1C0212023-12-18
00850053916205IDG/Sanzay1HC3012024-07-03
00850053916267IDG/Sanzay1QS012024-07-03
00850053916113IDG/Sanzay1C2432024-06-25
00850053916236IDG/Sanzay1QC012024-06-25
00850053916243IDG/Sanzay1QC022024-06-25
00850053916137IDG/Sanzay1C3432024-01-12
00850053916076IDG/Sanzay1C1052024-01-15
00850053916120IDG/Sanzay1C3212024-01-12
00850053916144IDG/Sanzay1C3912024-01-12
00850053916151IDG/Sanzay1C4032024-01-12
00850053916168IDG/Sanzay1C4132024-01-12
00850053916175IDG/Sanzay1C5012024-01-12
00850053916182IDG/Sanzay1HC1012024-01-12
00850053916199IDG/Sanzay1HC2012024-01-12
00850053916069IDG/Sanzay1C0952024-01-09
00850053916083IDG/Sanzay1C1232024-01-09
00850053916090IDG/Sanzay1C1532024-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00893038002890Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
00893038002913Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
00893038002920Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
00893038002937Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
04050598010437ox-LDL ELISAImmundiagnostik AGLBS2023-06-21
04050598010444ox-LDL ELISAImmundiagnostik AGLBS2023-06-21
05055273201185DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2022-10-04
05055273208412DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2022-10-04
05055273208481DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2022-10-04
00630414610832Atellica CH HDLCSiemens Healthcare Diagnostics Inc.LBS2022-07-08
00630414305059Atellica CH HDLCSiemens Healthcare Diagnostics Inc.LBS2022-07-08
04015630926879HDL-Cholesterol plus 3rd generationRoche Diagnostics GmbHLBS2021-02-08
00630414508436ADVIA® Chemistry D-HDL Direct HDL Cholesterol ReagentsSiemens Healthcare Diagnostics Inc.LBS2020-09-24
00630414551784ADVIA® Chemistry D-HDL Direct HDL Cholesterol ReagentsSiemens Healthcare Diagnostics Inc.LBS2020-09-24
00630414596204Atellica™ CH D-HDLSiemens Healthcare Diagnostics Inc.LBS2020-09-24
10758750001668VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LBS2020-04-18
10758750002825VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LBS2020-04-18
00380740161484ARCHITECTAbbott GmbHLBS2020-03-21
07613336121306HDL-Cholesterol Gen.4Roche Diagnostics GmbHLBS2020-03-05
05055273208467DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2019-06-03
00386100002077HDL CHOL Reagent KitMEDICA CORPORATIONLBS2019-02-14
05055273201291HDLRANDOX LABORATORIES LIMITEDLBS2018-12-24
04015630942589HDL-Cholesterol Gen.4Roche Diagnostics GmbHLBS2018-12-07
00380740129989AlinityAbbott GmbHLBS2018-08-08
00380740129996AlinityAbbott GmbHLBS2018-08-08
00380740005313ARCHITECTABBOTT LABORATORIESLBS2018-07-31
00817274022252JAS DiagnosticsDREW SCIENTIFIC, INC.LBS2018-06-04
00852169008164ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) CholesterolCLEARCHEM DIAGNOSTICS INC.LBS2018-05-18
00852169008201ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) CholesterolCLEARCHEM DIAGNOSTICS INC.LBS2018-05-18
00857969006532ACEALFA WASSERMANN, INC.LBS2017-10-10