FDA.report

HDL-CHOLESTEROL (HDL)

Primary DI
05055273201161
Brand
HDL-CHOLESTEROL (HDL)
Company
RANDOX LABORATORIES LIMITED
Model
CH203
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LBRLdl & Vldl Precipitation, Hdl

Product Code Classifications

CodeDeviceSpecialtyClass
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055273201161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055273201161050552732011615055273201161

GMDN Terms

TermDefinition
High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods

Method

Regulatory Flags

DUNS number
227530649
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05055273210118LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)LIA5143LIA51432025-03-24
05055273210125LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3)LIA5144LIA51442025-03-24
05055273219814PTH CONTROL LEVEL 1 (PTH CONTROL 1)PTH10608PTH106082025-03-24
05055273219821PTH CONTROL LEVEL 2 (PTH CONTROL 2)PTH10609PTH106092025-03-24
05055273219838PTH CONTROL LEVEL 3 (PTH CONTROL 3)PTH10610PTH106102025-03-24
05055273219043LIQUID CARDIAC CONTROL 1CQ10534CQ105342025-03-21
05055273219050LIQUID CARDIAC CONTROL 2CQ10535CQ105352025-03-21
05055273219067LIQUID CARDIAC CONTROL 3CQ10536CQ105362025-03-21
05055273219128LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1)CQ10616CQ106162025-03-21
05055273219135LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2)CQ10617CQ106172025-03-21
05055273219142LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3)CQ10618CQ106182025-03-21
05055273219159Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)LAL10565LAL105652025-03-21
05055273219166Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)LAN105662025-03-21
05055273219173Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3)LAE10567LAE105672025-03-21
05055273219180Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)LAL10625 LAL10625 2025-03-21
05055273219197Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)LAN10626LAN106262025-03-21
05055273219203Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3)LAE10627LAE106272025-03-21
05055273220018PlaySafe™ SCK10690SCK106902024-10-01

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00850053916175IDG/SanzayIDG/SANZAY CorporationLBR2024-01-12
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
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
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04987481164543L-Type LDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
10381934722013CardioChek Plus Home Lipid Panel Self-Test Strip 2ctPOLYMER TECHNOLOGY SYSTEMS, INC.LBR2021-02-08
04015630934584LDL-Cholesterol Gen.3Roche Diagnostics GmbHLBR2021-02-08
04015630934591LDL-Cholesterol Gen.3Roche Diagnostics GmbHLBR2021-02-08
00811727016171Pointe autoHDL Cholesterol ReagentPOINTE SCIENTIFIC, INC.LBR2021-01-30
03610230007044Yumizen C1200 HDL DirectHORIBA ABX SASLBR2020-11-02
04987481164581L-Type HDL-C Reagent 1FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2020-10-23
04987481164598L-Type HDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2020-10-23
03610230007099Yumizen C1200 LDL DirectHORIBA ABX SASLBR2020-08-28
00811727015860Pointe autoHDL for the BS480POINTE SCIENTIFIC, INC.LBR2020-05-28
10758750009527VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LBR2020-04-18
07613336121375LDL-Cholesterol Gen.3Roche Diagnostics GmbHLBR2020-03-05
00850006113064Curo L5KPI HEALTHCARE, INC.LBR2019-04-26
00817302022667CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667CAROLINA LIQUID CHEMISTRIES CORPORATIONLBR2018-08-27
00380740129972AlinityABBOTT LABORATORIESLBR2018-07-11
00852169008201ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) CholesterolCLEARCHEM DIAGNOSTICS INC.LBR2018-05-18
05060500091996Synermed®INFRARED LABORATORY SYSTEMS LLCLBR2017-02-28
20304040037731CardioChekHENRY SCHEIN, INC.LBR2017-01-05
10304040037741CardioChekHENRY SCHEIN, INC.LBR2017-01-05
10856626006097L-Type HDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2016-11-23