FDA.reportPublic FDA data

ADVIA Centaur Herpes-1 IgG

Primary DI
00630414016740
Brand
ADVIA Centaur Herpes-1 IgG
Company
Siemens Healthcare Diagnostics Inc.
Model
10720846
Catalog number
10720846
Device description
Herpes-1 IgG (HSV1) ADVIA Centaur - RGT – 100T
Published
2019-04-09
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
MXJEnzyme linked immunosorbent assay, herpes simplex virus, hsv-1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181333000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181333000ADVIA Centaur Herpes-1 IgGBiokit, S.A.2018-08-23MXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414016740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414016740006304140167406304140167400630414016740

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 (HSV1) 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 1 (HSV1) 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.
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
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
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870024332HSV 1+2 IgG AccuLite® CLIA Test System (6775-300A, 6775-300B)MONOBIND, INC.MXJ2024-09-13
00816870024363HSV 1+2 IgM AccuBind® ELISA Test System (6825-300A, 6825-300B)MONOBIND, INC.MXJ2024-09-13
00816870024370HSV 1+2 IgM AccuLite® CLIA Test System (6875-300A, 6875-300B)MONOBIND, INC.MXJ2024-09-13
00380740197704AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00380740213879AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00380740213886AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00850054026095AccuDiag ™Diagnostic Automation, Inc.MXJ2023-06-27
07613336170656Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2022-12-06
07613336170663Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2022-12-06
00842768022784Atellica IM Herpes-1 IgGSiemens Healthcare Diagnostics Inc.MXJ2022-10-28
03610522051076Bio-RadBio-RAD Laboratories, Inc.MXJ2019-05-28
10816101022356DxSelect™ - 10X Wash BufferDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022363HSV-1 IgG Antigen WellsDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022387HerpeSelect ELISA Sample DiluentDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022301DxSelect™ - Stop ReagentDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022295DxSelect™ - Substrate ReagentDIASORIN MOLECULAR LLCMXJ2017-07-11
04015630940431Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2017-04-21
00850487007135ReQuestQUEST INTERNATIONAL, INC.MXJ2016-11-30
00850487007548SeraQuestQUEST INTERNATIONAL, INC.MXJ2016-11-30
08056771600231LIAISON® HSV-1 Type Specific IgGDiasorin Inc.MXJ2016-09-24
08056771600248LIAISON® Control HSV-1 IgGDiasorin Inc.MXJ2016-09-24
04049016096726Anti-HSV-1 (gC1) ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMXJ2016-09-24
05391516743471Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
05391516743488Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
05391516747035Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
10816101022073HSV-1 ELISA IgG Cutoff CalibratorDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022080HSV ELISA Negative ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022097HSV-1 ELISA IgG High Positive ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022103HSV-1 ELISA IgG Low Positive ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022165HSV-1 ELISA IgG ConjugateDIASORIN MOLECULAR LLCMXJ2016-09-22