FDA.reportPublic FDA data

N Antisera to Human IgG

Primary DI
00842768009808
Brand
N Antisera to Human IgG
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10446299
Catalog number
OSAS19
Device description
Quantitative determination of IgG in human serum, plasma and CSF on BN Systems
Published
2016-09-24
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
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
K083445000
K233663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083445000N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LCSiemens Healthcare Diagnostics2009-03-24CFN
K233663000N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH2023-12-13CFN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768009808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768009808008427680098088427680098080842768009808

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(800)664-3822XX@XX.XX
+1(800)664-3822CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414634029INNOVANCE D-Dimer 2.010873803108738032026-08-19
00630414634210INNOVANCE D-Dimer 2.0 Diluent10873807108738072026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 310873806108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 210873805108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 110873804108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 110874091108740912026-08-19
00630414656014INNOVANCE D-Dimer 2.010874090108740902026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 210874092108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 310874093108740932026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENT10874094108740942026-08-19
00630414312446N FLC Supplementary Reagent10873769108737692026-06-26
00630414285054N Latex ADNase B (USA)10873691108736912020-07-07
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24

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
00630414596266Atellica CH IgG_2Siemens Healthcare Diagnostics Inc.CFN2017-12-27
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