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Elecsys Rubella IgG Immunoassay

Primary DI
04015630939251
Brand
Elecsys Rubella IgG Immunoassay
Company
Roche Diagnostics GmbH
Model
4618793160
Catalog number
4618793160
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
LFXENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFXEnzyme Linked Immunoabsorbent Assay, RubellaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072617000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072617000ELECSYS RUBELLA IGG IMMUNOASSAYRoche Diagnostics Corp.2008-12-05LFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630939251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630939251040156309392514015630939251

GMDN Terms#

Term, Definition table
TermDefinition
Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen, using an enzyme immunoassay (EIA) 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
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