FDA.reportPublic FDA data

IDG/Sanzay

Primary DI
00850053916175
Brand
IDG/Sanzay
Company
IDG/SANZAY Corporation
Model
1
Catalog number
C501
Device description
The IDG HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease.
Published
2024-01-12
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
LBRLdl & Vldl Precipitation, Hdl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053916175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053916175008500539161758500539161750850053916175

GMDN Terms#

Term, Definition table
TermDefinition
High density lipoprotein (HDL) cholesterol IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Liter
Total Volume80Milliliter
Total Volume380Milliliter

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
00850053916250IDG/Sanzay1QS31D2024-06-25
00850053916137IDG/Sanzay1C3432024-01-12
00850053916076IDG/Sanzay1C1052024-01-15
00850053916120IDG/Sanzay1C3212024-01-12
00850053916144IDG/Sanzay1C3912024-01-12
00850053916151IDG/Sanzay1C4032024-01-12
00850053916168IDG/Sanzay1C4132024-01-12
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
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.LBR2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.LBR2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.LBR2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.LBR2026-03-09
10682607690050Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.LBR2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.LBR2026-03-09
10682607690081Mission Cholesterol Control SolutionAcon Laboratories, Inc.LBR2026-03-09
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.LBR2024-07-12
10673486001907Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-MatrixTECO DIAGNOSTICSLBR2023-11-20
10673486001938Teco Diagnostics HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-20
10673486001884Teco Diagnostics HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-10
10673486001891Teco Diagnostics Direct HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-10
00381934753010Lipid Panel, 15ct., CCPlus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-06-20
00381934752013Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)POLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-06-01
00887473000337STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-05-10
00887473000344STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-05-10
00887473000320STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.LBR2023-04-07
00381934747019Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-03-25
10381934747016Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-03-25
00381934749013Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-03-25
00887473000290STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-03-17
00887473000306STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-03-17
00887473000283STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.LBR2023-03-17
00381934750019CardioChek Plus Home Self-Test AnalyzerPOLYMER TECHNOLOGY SYSTEMS, INC.LBR2022-04-11
14987481164533L-Type LDL-C Reagent 1FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
14987481164540L-Type LDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
04987481164536L-Type LDL-C Reagent 1FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
04987481164543L-Type LDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01