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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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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