FDA.reportPublic FDA data

IMMULITE® 2000 Systems CVG CMV IgG

Primary DI
00630414961231
Brand
IMMULITE® 2000 Systems CVG CMV IgG
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381309
Catalog number
L2KCVG2
Device description
CMV IgG Ab - IMMULITE - RGT - 200 Tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFZENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFZEnzyme Linked Immunoabsorbent Assay, CytomegalovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993952000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993952000IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6Diagnostic Products Corp.1999-12-16LFZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414961231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414961231006304149612316304149612310630414961231

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) 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 cytomegalovirus (CMV) 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
00816870024240CMV IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFZ2024-09-13
00816870024257CMV IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFZ2024-09-13
00816870024288CMV IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFZ2024-09-13
00816870024295CMV IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFZ2024-09-13
04048474027976CMV IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLFZ2023-08-29
00840239027979CMV IgG ELISA DRG International IncLFZ2023-08-24
00380740181093AlinityAbbott Ireland DiagnosticsLFZ2023-07-14
00380740181109AlinityAbbott Ireland DiagnosticsLFZ2023-07-14
07613336193082Elecsys CMV IgGRoche Diagnostics GmbHLFZ2022-12-07
07613336198469Elecsys CMV IgGRoche Diagnostics GmbHLFZ2022-12-06
00894175000558AccuDiag™Diagnostic Automation, Inc.LFZ2021-11-29
00894175000053AccuDiag ™ Diagnostic Automation, Inc.LFZ2021-08-10
B3507203200Gold Standard Diagnostics Is-CMV IgG ELISA Test KitGold Standard Diagnostics CorporationLFZ2020-06-03
05391516746885Trinity BiotechCLARK LABORATORIES, INC.LFZ2019-12-27
00630414588872ADVIA Centaur CMV IgGSiemens Healthcare Diagnostics Inc.LFZ2019-02-10
00630414246635Atellica IM CMV IgGSiemens Healthcare Diagnostics Inc.LFZ2018-11-30
03610520150269BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
03610521167488BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
03610520992715BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
04015630940172Elecsys CMV IgGRoche Diagnostics GmbHLFZ2017-04-21
04015630940189Elecsys CMV IgMRoche Diagnostics GmbHLFZ2017-04-17
08056771101943LIAISON® CMV IgMDIASORIN SPALFZ2016-09-24
00630414963822IMMULITE®/IMMULITE® 1000 Systems CMV CMV IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFZ2016-09-24
05391516745024Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-22
05391516745031Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-22
05391516743419Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
05391516743426Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
05391516746991Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
04015630937172Elecsys CMV IgG AssayRoche Diagnostics GmbHLFZ2016-09-20
04015630938926Elecsys CMV IgM ImmunoassayRoche Diagnostics GmbHLFZ2016-09-20