FDA.reportPublic FDA data

HDL-Cholesterol Gen.4

Primary DI
07613336121306
Brand
HDL-Cholesterol Gen.4
Company
Roche Diagnostics GmbH
Model
08057877190
Catalog number
08057877190
Published
2020-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K162593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162593000HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)2016-10-19LBS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336121306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336121306076133361213067613336121306

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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07613336218341Elecsys CA 19-909755608190097556081902026-06-01
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07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053916250IDG/SanzayIDG/SANZAY CorporationLBS2024-06-25
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
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