FDA.reportPublic FDA data

IMMULITE® / IMMULITE® 1000 Systems HER Herpes I and II IgG

Primary DI
00630414964171
Brand
IMMULITE® / IMMULITE® 1000 Systems HER Herpes I and II IgG
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381274
Catalog number
LKHS1
Device description
HSV I and II IgG Ab - IMMULITE - RGT - 100 Tests
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGCEnzyme linked immunoabsorbent assay, herpes simplex virus, non-specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-SpecificMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950670000IMMULITE HERPES I AND II IGGDiagnostic Products Corp.1996-06-21LGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414964171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414964171006304149641716304149641710630414964171

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) 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 and/or herpes simplex virus 2 (HSV1 & 2) 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
00850054026644QMedix™Diagnostic Automation, Inc.LGC2024-06-25
08426951056439biokitHSV-2BIOKIT, S.A.LGC2022-10-10
00894175000046AccuDiag ™ Diagnostic Automation, Inc.LGC2021-08-10
B3507203400Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test KitGold Standard Diagnostics CorporationLGC2020-08-28
B3507203500Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test KitGold Standard Diagnostics CorporationLGC2020-06-03
00630414016726ADVIA Centaur Herpes-2 IgGSiemens Healthcare Diagnostics Inc.LGC2019-04-09
00630414999784IMMULITE® 2000 Systems Herpes I and II IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLGC2016-09-24
05391516743709Trinity BiotechCLARK LABORATORIES, INC.LGC2016-09-23
05391516746489Trinity BiotechCLARK LABORATORIES, INC.LGC2016-09-23
10816101021014HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen StripsDIASORIN MOLECULAR LLCLGC2016-09-22
10816101021021HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive ControlDIASORIN MOLECULAR LLCLGC2016-09-22
10816101021038HSV-1 and HSV-2 Immunoblot IgG Negative ControlDIASORIN MOLECULAR LLCLGC2016-09-22
20816101021004HerpeSelect® 1 and 2 Immunoblot IgGDIASORIN MOLECULAR LLCLGC2016-09-22
00817273020174DiamedixDIAMEDIX CORPORATIONLGC2016-09-20
05391516746496Trinity BiotechCLARK LABORATORIES, INC.LGC2016-09-19
00847865010740Bio-Rad Laboratories, Inc.Bio-RAD Laboratories, Inc.LGC2016-09-12
00850487007142ReQuestQUEST INTERNATIONAL, INC.LGC2016-08-31
00850487007333SeraQuestQUEST INTERNATIONAL, INC.LGC2016-08-31
00811727015211Pointe Scientific, Inc. HSV-1 & 2 IgGHORIBA INSTRUMENTS INCORPORATEDLGC2016-08-31
00816057020577ASI HSV IgG EIA TestARLINGTON SCIENTIFIC, INC.LGC2016-07-08