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
Primary DIBrandModelCatalogPublished
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
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740197742AlinityAbbott Ireland DiagnosticsMYF2025-10-14
00380740213893AlinityAbbott Ireland DiagnosticsMYF2025-10-14
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
00847865010993BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12