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

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00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
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00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816870024370HSV 1+2 IgM AccuLite® CLIA Test System (6875-300A, 6875-300B)MONOBIND, INC.MXJ2024-09-13
00380740197704AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
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00850054026095AccuDiag ™Diagnostic Automation, Inc.MXJ2023-06-27
07613336170656Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2022-12-06
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03610522051076Bio-RadBio-RAD Laboratories, Inc.MXJ2019-05-28
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10816101022387HerpeSelect ELISA Sample DiluentDIASORIN MOLECULAR LLCMXJ2017-07-11
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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
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10816101022103HSV-1 ELISA IgG Low Positive ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
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