FDA.reportPublic FDA data

Atellica IM Rub G QC

Primary DI
00630414600536
Brand
Atellica IM Rub G QC
Company
Siemens Healthcare Diagnostics Inc.
Model
10995671
Catalog number
10995671
Device description
Rubella IgG (Rub G) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL
Published
2018-02-06
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
LFXENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003412000ADVIA CENTAUR RUBELLA IGG ASSAYBayer Corp.2001-04-13LFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414600536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414600536006304146005366304146005360630414600536

GMDN Terms#

Term, Definition table
TermDefinition
Rubella virus immunoglobulin G (IgG) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, 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
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27
00630414597508Atellica CH hsCRP Calibrator11099412110994122017-12-22
00630414597515Atellica CH CRP_2 Calibrator11099430110994302017-12-22
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414611297Atellica CH RCRP Cal11537245115372452024-02-02
00842768037726Dimension EXL LOCI Troponin I High Sensitive10471068104710682019-10-16
00630414596099Atellica CH Thc11097503110975032017-12-27
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414653259Atellica CH Crea311537567115375672026-05-08

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
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
00630414964614IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24
00630414971469IMMULITE® 2000 Systems RUM Rubella IgMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24