FDA.reportPublic FDA data

IMMULITE®/IMMULITE® 1000 Systems HCY Homocysteine

Primary DI
00630414964157
Brand
IMMULITE®/IMMULITE® 1000 Systems HCY Homocysteine
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381029
Catalog number
LKHO1
Device description
Homocystein - 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
LPSURINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPSUrinary Homocystine (Nonquantitative) Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003597000IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2Diagnostic Products Corp.2001-02-05LPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414964157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414964157006304149641576304149641570630414964157

GMDN Terms#

Term, Definition table
TermDefinition
Homocysteine IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of homocysteine 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
00817089021464DiazymeDIAZYME LABORATORIES, INC.LPS2020-07-21
00811727015877Pointe Homocysteine for BS480HORIBA INSTRUMENTS INCORPORATEDLPS2020-05-28
07613336121290Homocysteine Enzymatic AssayRoche Diagnostics GmbHLPS2020-03-16
00380740153496AlinityAbbott GmbHLPS2018-12-04
00630414599298Atellica IM HCYSiemens Healthcare Diagnostics Inc.LPS2018-02-06
00630414599304Atellica IM HCYSiemens Healthcare Diagnostics Inc.LPS2018-02-06
00630414599311Atellica IM HCY DILSiemens Healthcare Diagnostics Inc.LPS2018-02-06
00630414599328Atellica IM HCY MCMSiemens Healthcare Diagnostics Inc.LPS2018-02-06
00380740156527ARCHITECTAbbott GmbHLPS2018-01-03
00817089020306DiazymeDIAZYME LABORATORIES, INC.LPS2016-11-03
00817089020948DiazymeDIAZYME LABORATORIES, INC.LPS2016-11-03
00817089020955DiazymeDIAZYME LABORATORIES, INC.LPS2016-11-03
00817439020918MedTest DX HomocysteineMedtest Dx, Inc.LPS2016-09-30
00817439020925MedTest DX Homocysteine ControlsMedtest Dx, Inc.LPS2016-09-30
14560189212777ST AIA-PACK HomocysteineTOSOH CORPORATIONLPS2016-09-24
04560189212817ST AIA-PACK Homocysteine Pretreatment SetTOSOH CORPORATIONLPS2016-09-24
05055273208894HCYRANDOX LABORATORIES LIMITEDLPS2016-09-24
00842768006128DImension Vista® Homocysteine Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHLPS2016-09-24
00842768006715N Latex HCYSiemens Healthcare Diagnostics Products GmbHLPS2016-09-24
00630414468174ADVIA Centaur® HCYSiemens Healthcare Diagnostics Inc.LPS2016-09-24
00630414468181ADVIA Centaur® HCYSiemens Healthcare Diagnostics Inc.LPS2016-09-24
00630414468211ADVIA Centaur® HCY DILSiemens Healthcare Diagnostics Inc.LPS2016-09-24
00630414468235ADVIA Centaur® HCY MCMSiemens Healthcare Diagnostics Inc.LPS2016-09-24
00630414953892IMMULITE® 2000 Systems HCY Homocysteine Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLPS2016-09-24
00630414961620IMMULITE® 2000 Systems HCY HomocysteineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLPS2016-09-24
08426950453024HemosIL HomocysteineINSTRUMENTATION LABORATORY COMPANYLPS2016-09-23
04015630927326Homocysteine Enzymatic AssayRoche Diagnostics GmbHLPS2016-09-20
04015630929979Homocysteine Enzymatic AssayRoche Diagnostics GmbHLPS2016-09-20
04015630933631Homocysteine Enzymatic AssayRoche Diagnostics GmbHLPS2016-09-20
00817302020014CAROLINA LIQUID CHEMISTRIES CORP. ® HCY RGT. KIT BL-201CAROLINA LIQUID CHEMISTRIES CORPORATIONLPS2016-09-01