IDG/Sanzay C501

GUDID 00850053916175

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.

IDG/SANZAY Corporation

High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent
Primary Device ID00850053916175
NIH Device Record Key17444410-bdd7-48d5-a15e-691eb53c55fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDG/Sanzay
Version Model Number1
Catalog NumberC501
Company DUNS948875013
Company NameIDG/SANZAY Corporation
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter
Total Volume80 Milliliter
Total Volume380 Milliliter
Total Volume1 Liter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850053916175 [Primary]

FDA Product Code

LBRLdl & Vldl Precipitation, Hdl

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-22
Device Publish Date2024-01-12

On-Brand Devices [IDG/Sanzay]

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00850053916014For the quantitative determination of alkaline phosphatase in human serum.
00850053916038For the quantitative determination of aspartate aminotransferase (AST) in human serum. The reage
00850053916229The IDG Control Level 2 Low Abnormal is intended for use for quality assurance of in vitro diagn
00850053916212The IDG Control Level 1 Normal is intended for use in quality assurance of in vitro diagnostic c
00850053916199The IDG APTT-EA reagent is an in vitro diagnostic assay intended for use in determining activate
00850053916182The IDG PT-HS reagent is an in vitro diagnostic assay intended for use in performing the one sta
00850053916175The IDG HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High
00850053916168For the in vitro quantitative determination of Uric Acid in serum.
00850053916151For the in vitro quantitative determination of Triglycerides in serum or plasma.
00850053916144For the quantitative determination of total protein concentration in human serum.
00850053916137Lactate Dehydrogenase LS (LDH-L) liquid reagent is intended to use for the In Vitro quantitative
00850053916120Inorganic phosphorus (UV method) reagent is for the quantitative determination of inorganic phos
00850053916076For the quantitative determination of calcium concentration in serum or plasma.
00850053916250The HDL-LDL calibrator is used to establish the value of high density lipoprotein cholesterol an
00850053916243For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accura
00850053916236For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accura
00850053916113For the In Vitro quantitative determination of glucose in human serum or plasma.
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