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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391523442121Multichem ID-HIV p24 TECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
05391523442251Multichem ID-HIV p24 Mini KitTECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
05391523442435Multichem ID-HIV p24 TECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
15099590806453Access anti-HAV IgM CalibratorBeckman Coulter, Inc.QCH2026-04-23
00380740197643AlinityAbbott GmbHQCH2023-11-04
00380740174347AlinityAbbott GmbHQCH2022-11-26
08056771602976LIAISON MeMed BV Control SetDiasorin Inc.QCH2022-08-10
00630414607054DV/DM COV2G/CV2G POS/NEG CTRLSiemens Healthcare Diagnostics Inc.QCH2021-01-22
00630414298405DV/DM COV2G/CV2G POS/NEG CTRLSiemens Healthcare Diagnostics Inc.QCH2021-01-22
00630414247038ADVIA Centaur Zika Ab QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414286846Atellica IM Zika IgM ControlsSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414286860Atellica IM Zika Ab QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
08056771602648LIAISON® XL Zika Capture IgM II Control SetDiasorin Inc.QCH2019-12-04
07613336129746PreciControl Anti-HAV IIRoche Diagnostics GmbHQCH2019-09-30
00630414587448ADVIA Centaur CMV IgG QCSiemens Healthcare Diagnostics Inc.QCH2019-02-10
00630414246482Atellica IM CMV IgG Quality ControlSiemens Healthcare Diagnostics Inc.QCH2018-11-30