FDA.reportPublic FDA data

Elecsys AntiHAV IgM

Primary DI
04015630938858
Brand
Elecsys AntiHAV IgM
Company
Roche Diagnostics GmbH
Model
11820591160
Catalog number
11820591160
Published
2016-09-20
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
LOLHepatitis a test (antibody and igm antibody)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOLHepatitis A Test (Antibody And Igm Antibody)Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093955000
K260048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093955000ANTI-HAV IGMRoche Diagnostics2010-06-22LOL
K260048000Elecsys Anti-HAV IgMRoche Diagnostics2026-04-07LOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630938858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630938858040156309388584015630938858

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis A virus in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23
07613336218402Elecsys LH09755721190097557211902026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590806446Access anti-HAV IgMBeckman Coulter, Inc.LOL2026-04-23
00380740197650AlinityAbbott GmbHLOL2023-11-04
00630414301259Atellica IM aHAVMSiemens Healthcare Diagnostics Inc.LOL2021-01-15
00630414301297Atellica IM aHAVTSiemens Healthcare Diagnostics Inc.LOL2021-01-15
00380740136628AlinityAbbott GmbHLOL2020-12-23
00380740131371AlinityAbbott GmbHLOL2020-11-06
00380740131562AlinityAbbott GmbHLOL2020-01-06
00380740131579AlinityAbbott GmbHLOL2020-01-06
00380740136611AlinityAbbott GmbHLOL2020-01-06
07613336129715Elecsys Anti-HAV IIRoche Diagnostics GmbHLOL2019-09-30
07613336129722Elecsys Anti-HAV IIRoche Diagnostics GmbHLOL2019-09-30
00630414597737Atellica IM aHAVMSiemens Healthcare Diagnostics Inc.LOL2017-12-27
00630414597744Atellica IM aHAVM QCSiemens Healthcare Diagnostics Inc.LOL2017-12-27
00630414597775Atellica IM aHAVT QCSiemens Healthcare Diagnostics Inc.LOL2017-12-27
00630414597768Atellica IM aHAVTSiemens Healthcare Diagnostics Inc.LOL2017-12-22
04015630939855Elecsys Anti-HAV IgMRoche Diagnostics GmbHLOL2017-09-07
04015630939916Elecsys Anti-HAVRoche Diagnostics GmbHLOL2017-06-20
08056771100199LIAISON® anti-HAVDIASORIN SPALOL2016-09-24
08056771100205LIAISON® Control anti-HAVDIASORIN SPALOL2016-09-24
00630414479996ADVIA Centaur® HAV IgMSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414480008ADVIA Centaur® HAV IgM QCSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414481876ADVIA Centaur® aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414481883ADVIA Centaur® Systems QC aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414498461ADVIA Centaur® aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414509259ADVIA Centaur® aHAVT QCSiemens Healthcare Diagnostics Inc.LOL2016-09-24
04015630938841Elecsys AntiHAV AssayRoche Diagnostics GmbHLOL2016-09-20
00847865012362MONOLISABIO-RADLOL2016-09-12
00847865012379MONOLISABIO-RADLOL2016-09-12
00380740011079ARCHITECTAbbott GmbHLOL2016-09-09
00380740011086ARCHITECTAbbott GmbHLOL2016-09-09