FDA.reportPublic FDA data

ADVIA Centaur Zika Ab 100T

Primary DI
00630414247021
Brand
ADVIA Centaur Zika Ab 100T
Company
Siemens Healthcare Diagnostics Inc.
Model
11202473
Catalog number
11202473
Device description
Zika Ab ADVIA Centaur Assay Kit 100T
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
QFOZika virus serological reagents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFOZika Virus Serological ReagentsMicrobiology2

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
00630414247021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414247021006304142470216304142470210630414247021

GMDN Terms#

Term, Definition table
TermDefinition
Zika virus 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 Zika virus in a clinical specimen, using a chemiluminescent immunoassay method.

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
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607158000106DPP Zika IgM SystemChembio Diagnostic Systems Inc.QFO2020-08-06
00630414247007ADVIA Centaur Zika IgM 50TSiemens Healthcare Diagnostics Inc.QFO2020-02-24
00630414286839Atellica IM Zika IgM 50TSiemens Healthcare Diagnostics Inc.QFO2020-02-24
00630414286853Atellica IM Zika Ab 100TSiemens Healthcare Diagnostics Inc.QFO2020-02-24
08056771602624LIAISON® XL Zika Capture IgM IIDiasorin Inc.QFO2019-12-04
B379ZKM21ZIKV Detect™ 2.0 IgM Capture ELISAINBIOS INTERNATIONAL, INCQFO2019-05-24