FDA.reportPublic FDA data

Atellica IM Herpes-2 IgG

Primary DI
00842768022807
Brand
Atellica IM Herpes-2 IgG
Company
Siemens Healthcare Diagnostics Inc.
Model
10733033
Catalog number
10733033
Device description
Herpes-2 IgG (HSV2) Atellica IM - RGT - 100T
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYFEnzyme linked immunosorbent assay, herpes simplex virus, hsv-2

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181334000ADVIA Centaur Herpes-2 IgGBiokit, S.A.2018-08-23MYF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768022807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768022807008427680228078427680228070842768022807

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 2 (HSV2) 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 herpes simplex virus 2 (HSV2) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Store upright, protect from light, do not freeze, resuspend

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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
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00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
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00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380740213909AlinityAbbott Ireland DiagnosticsMYF2025-10-14
00850054026088AccuDiag ™Diagnostic Automation, Inc.MYF2023-06-27
07613336170687Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2022-12-06
07613336170694Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2022-12-06
03610522051236Bio-RadBio-RAD Laboratories, Inc.MYF2019-05-28
00630414016726ADVIA Centaur Herpes-2 IgGSiemens Healthcare Diagnostics Inc.MYF2019-04-09
10816101022370HSV-2 IgG Antigen WellsDIASORIN MOLECULAR LLCMYF2017-07-11
04015630940448Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2017-04-21
00850487007128ReQuest QUEST INTERNATIONAL, INC.MYF2016-10-31
08056771600101LIAISON® HSV-2 Type Specific IgGDiasorin Inc.MYF2016-09-24
04049016096733Anti-HSV-2 (gG2) ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMYF2016-09-24
05391516743501Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-23
05391516743518Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-23
05391516747059Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-23
10816101022110HSV-2 ELISA IgG Cutoff CalibratorDIASORIN MOLECULAR LLCMYF2016-09-22
10816101022127HSV-2 ELISA IgG High Positive ControlDIASORIN MOLECULAR LLCMYF2016-09-22
10816101022134HSV-2 ELISA IgG Low Positive ControlDIASORIN MOLECULAR LLCMYF2016-09-22
10816101022172HSV-2 ELISA IgG ConjugateDIASORIN MOLECULAR LLCMYF2016-09-22
20816101022186HerpeSelect® 2 ELISA IgGDIASORIN MOLECULAR LLCMYF2016-09-22
20816101022193HerpeSelect® 2 ELISA IgGDIASORIN MOLECULAR LLCMYF2016-09-22
05391516743327Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-21
05391516746939Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-21
04015630939053Elecsys HSV2 IgG ImmunoassayRoche Diagnostics GmbHMYF2016-09-20
00847865000949BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
00847865002172BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
00847865002479BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
00847865004725BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
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