FDA.reportPublic FDA data

IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG

Primary DI
00630414964614
Brand
IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381292
Catalog number
LKRUB1
Device description
Rubella IgG Ab - IMMULITE - RGT - 100 Tests
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFXENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFXEnzyme Linked Immunoabsorbent Assay, RubellaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963613000IMMULITE RUBELLA IGGDiagnostic Products Corp.1997-04-02LFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414964614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414964614006304149646146304149646140630414964614

GMDN Terms#

Term, Definition table
TermDefinition
Rubella virus immunoglobulin G (IgG) 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 G (IgG) antibodies to Rubella virus in a clinical specimen, using a chemiluminescent immunoassay 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
296822794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740168780AlinityAbbott Ireland DiagnosticsLFX2025-12-11
07613336218440Elecsys Rubella IgMRoche Diagnostics GmbHLFX2024-10-24
00816870024165Rubella IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFX2024-09-13
00816870024172Rubella IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFX2024-09-13
00816870024202Rubella IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFX2024-09-13
00816870024219Rubella IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFX2024-09-13
00850049545686AccuDiag ™Diagnostic Automation, Inc.LFX2023-06-14
00850049545693AccuDiag ™Diagnostic Automation, Inc.LFX2023-06-14
B3507203600Gold Standard Diagnostics Is-Rubella IgG ELISA Test KitGold Standard Diagnostics CorporationLFX2020-07-27
05391516746519Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746526Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746533Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746878Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746748Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-26
05391516746786Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-26
00630414599830Atellica IM Rub MSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414599847Atellica IM Rub M QCSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414600529Atellica IM Rub GSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414600536Atellica IM Rub G QCSiemens Healthcare Diagnostics Inc.LFX2018-02-06
04015630940257Elecsys Rubella IgMRoche Diagnostics GmbHLFX2017-05-10
04015630940240Elecsys Rubella IgGRoche Diagnostics GmbHLFX2017-04-21
10859035006245Alere Rubella-plus®ALERE NORTH AMERICA, LLCLFX2016-09-24
08056771100571LIAISON® Rubella IgGDIASORIN SPALFX2016-09-24
00630414201412ADVIA Centaur® Rub GSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414201429ADVIA Centaur® Rub G QCSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414201436ADVIA Centaur® Rub MSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414201443ADVIA Centaur® Rub M QCSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414962054IMMULITE® 2000 Systems RUB Rubella Quantitative IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24
00630414962061IMMULITE® 2000 Systems RUB Rubella Quantitative IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24
00630414971469IMMULITE® 2000 Systems RUM Rubella IgMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24