FDA.reportPublic FDA data

Elecsys CMV IgM

Primary DI
04015630940189
Brand
Elecsys CMV IgM
Company
Roche Diagnostics GmbH
Model
07027133190
Catalog number
07027133190
Published
2017-04-17
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
LFZENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFZEnzyme Linked Immunoabsorbent Assay, CytomegalovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163569000Elecsys CMV IgMRoche Diagnostics2017-03-17LFZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630940189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630940189040156309401894015630940189

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) 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 cytomegalovirus (CMV) 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#

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07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
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07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
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07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
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04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
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20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
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07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
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07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870024240CMV IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFZ2024-09-13
00816870024257CMV IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFZ2024-09-13
00816870024288CMV IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFZ2024-09-13
00816870024295CMV IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFZ2024-09-13
04048474027976CMV IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLFZ2023-08-29
00840239027979CMV IgG ELISA DRG International IncLFZ2023-08-24
00380740181093AlinityAbbott Ireland DiagnosticsLFZ2023-07-14
00380740181109AlinityAbbott Ireland DiagnosticsLFZ2023-07-14
07613336193082Elecsys CMV IgGRoche Diagnostics GmbHLFZ2022-12-07
07613336198469Elecsys CMV IgGRoche Diagnostics GmbHLFZ2022-12-06
00894175000558AccuDiag™Diagnostic Automation, Inc.LFZ2021-11-29
00894175000053AccuDiag ™ Diagnostic Automation, Inc.LFZ2021-08-10
B3507203200Gold Standard Diagnostics Is-CMV IgG ELISA Test KitGold Standard Diagnostics CorporationLFZ2020-06-03
05391516746885Trinity BiotechCLARK LABORATORIES, INC.LFZ2019-12-27
00630414588872ADVIA Centaur CMV IgGSiemens Healthcare Diagnostics Inc.LFZ2019-02-10
00630414246635Atellica IM CMV IgGSiemens Healthcare Diagnostics Inc.LFZ2018-11-30
03610520150269BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
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03610520992715BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
04015630940172Elecsys CMV IgGRoche Diagnostics GmbHLFZ2017-04-21
08056771101943LIAISON® CMV IgMDIASORIN SPALFZ2016-09-24
00630414961231IMMULITE® 2000 Systems CVG CMV IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFZ2016-09-24
00630414963822IMMULITE®/IMMULITE® 1000 Systems CMV CMV IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFZ2016-09-24
05391516745024Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-22
05391516745031Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-22
05391516743419Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
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05391516746991Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
04015630937172Elecsys CMV IgG AssayRoche Diagnostics GmbHLFZ2016-09-20
04015630938926Elecsys CMV IgM ImmunoassayRoche Diagnostics GmbHLFZ2016-09-20