FDA.reportPublic FDA data

ADVIA Centaur Zika IgM QC

Primary DI
00630414247014
Brand
ADVIA Centaur Zika IgM QC
Company
Siemens Healthcare Diagnostics Inc.
Model
11202472
Catalog number
11202472
Device description
Zika IgM ADVIA Centaur Quality Control Material Kit 2 x 2 x 2.0 mL
Published
2020-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K191578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191578000ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality ControlSiemens Healthcare Diagnostics, Inc.2019-07-17QFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414247014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414247014006304142470146304142470140630414247014

GMDN Terms#

Term, Definition table
TermDefinition
Zika virus immunoglobulin M (IgM) 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 M (IgM) antibodies to Zika virus in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend
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
1
Lot or batch
true
Expiration date on label
true

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