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Elecsys CMV IgM Immunoassay

Primary DI
04015630938926
Brand
Elecsys CMV IgM Immunoassay
Company
Roche Diagnostics GmbH
Model
4784618160
Catalog number
4784618160
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
LFZENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142133000ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGMRoche Diagnostics2014-10-24LFZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630938926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630938926040156309389264015630938926

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
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07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816870024295CMV IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFZ2024-09-13
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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
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00894175000053AccuDiag ™ Diagnostic Automation, Inc.LFZ2021-08-10
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04015630940172Elecsys CMV IgGRoche Diagnostics GmbHLFZ2017-04-21
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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
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