FDA.reportPublic FDA data

ADVIA Centaur CMV IgG QC

Primary DI
00630414587448
Brand
ADVIA Centaur CMV IgG QC
Company
Siemens Healthcare Diagnostics Inc.
Model
10630613
Catalog number
10630613
Device description
CMV IgG ADVIA Centaur - Quality Control
Published
2019-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QCHAssayed quality control material for clinical microbiology assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCHAssayed Quality Control Material For Clinical Microbiology AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181213000ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.2018-07-30LFZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414587448PrimaryGS10
00630414224138Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414587448006304145874486304145874480630414587448
00630414224138006304142241386304142241380630414224138

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to cytomegalovirus (CMV) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Refridgerate, Protect from Light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
2
Lot or batch
true
Expiration date on label
true

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