FDA.reportPublic FDA data

Atellica CH IgG_2

Primary DI
00630414596266
Brand
Atellica CH IgG_2
Company
Siemens Healthcare Diagnostics Inc.
Model
11097616
Catalog number
11097616
Device description
Immunoglobulin G (IgG_2) Atellica CH - RGT 720T
Published
2017-12-27
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
CFNMETHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9926620008 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.2000-02-15MSJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414596266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414596266006304145962666304145962660630414596266

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin G (IgG total) in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
05051700021036Optilite® IgG3 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2023-09-27
05051700021043Optilite® IgG4 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2023-09-27
05051700020916Optilite® IgG Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2022-11-21
05051700020923Optilite® IgG1 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2022-11-21
05051700020930Optilite® IgG2 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2022-11-21
00630414285023N Latex IgMSiemens Healthcare Diagnostics Products GmbHCFN2020-05-29
05051700020183Optilite IgM CSF KitTHE BINDING SITE GROUP LIMITEDCFN2020-01-31
05051700020190Optilite IgA CSF KitTHE BINDING SITE GROUP LIMITEDCFN2019-06-21
00630414595627Atellica CH IgM_2Siemens Healthcare Diagnostics Inc.CFN2017-12-21
00630414595610Atellica CH IgA_2Siemens Healthcare Diagnostics Inc.CFN2017-12-19
05051700019835Optilite IgG CSF KitTHE BINDING SITE GROUP LIMITEDCFN2017-05-26
15099590011574AUBeckman Coulter, Inc.CFN2016-09-24
15099590011581AUBeckman Coulter, Inc.CFN2016-09-24
15099590011598AUBeckman Coulter, Inc.CFN2016-09-24
05051700006033Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006088Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006095Human IgA Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006101Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006118Olympus IgG3 KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006132Human IgG3 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917, Modular PTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006149Beckman Immage IgG3 Latex KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006163Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006170Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006187Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman Coulter AU® seriesTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006224Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006248Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006538Human IgA2 Subclass Liquid Latex Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700007535Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700007559Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700007566Human IgG1 Subclass Liquid Reagent Kit for use on the Beckman Coulter AU® seriesTHE BINDING SITE GROUP LIMITEDCFN2016-09-24