FDA.reportPublic FDA data

DImension Vista® Immunoglobulin G Subclass 4 Flex® Reagent Cartridge

Primary DI
00842768006296
Brand
DImension Vista® Immunoglobulin G Subclass 4 Flex® Reagent Cartridge
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445914
Catalog number
K7083
Device description
For the quantitative measurement of immunoglobulin G subclass 4 in human serum and plasma on the Dimension Vista® System
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
DFZIGG (GAMMA CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DFZIgg (Gamma Chain Specific), Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092283000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092283000DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGGSiemens Healthcare Diagnostics2009-10-21DFZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768006296PrimaryGS10
00842768020230Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768006296008427680062968427680062960842768006296
00842768020230008427680202308427680202300842768020230

GMDN Terms#

Term, Definition table
TermDefinition
Immunoglobulin G subclass (IgG subclass) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen.

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)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051700006064Hu IgG Subclass Liquid Reagent Kits for use on Hitachi 911/912/917 and Modular PTHE BINDING SITE GROUP LIMITEDDFZ2016-09-24
05051700007597Human IgG1 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and HitachTHE BINDING SITE GROUP LIMITEDDFZ2016-09-24
05051700007696Human IgG2 Subclass Hitachi KitTHE BINDING SITE GROUP LIMITEDDFZ2016-09-24
00842768006265DImension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDFZ2016-09-24
00842768006272DImension Vista® Immunoglobulin G Subclass 2 Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDFZ2016-09-24
00842768006289DImension Vista® Immunoglobulin G Subclass 3 Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDFZ2016-09-24