FDA.reportPublic FDA data

Diazyme

Primary DI
00817089020306
Brand
Diazyme
Company
DIAZYME LABORATORIES, INC.
Model
DZ568A-CON
Published
2016-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K071971000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071971000DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CALDiazyme Laboratories2007-09-17LPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817089020306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089020306008170890203068170890203060817089020306

GMDN Terms#

Term, Definition table
TermDefinition
Homocysteine IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of homocysteine in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080507219
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817089022690DiazymeDZ558A-KY12020-07-29
00817089020900Diazyme Procalcitonin AssayDZ558A-K2017-09-01
00817089022478DiazymeDZ248A-CON2026-01-21
00817089023048DiazymeDZ122A-KY12026-01-21
00817089023222Diazyme100148B-CAL2026-01-21
00817089023239Diazyme100148B-CON2026-01-21
00817089021358DiazymeDZ168C-CAL2020-07-21
00817089021365DiazymeDZ168C-CON2020-07-21
00817089021464DiazymeDZ568A-CA52020-07-21
00817089020047DiazymeDZ122A-CAL2016-11-03
00817089020054DiazymeDZ122A-CON2016-11-03
00817089020504DiazymeDZ042A-CAL2016-11-03
00817089020511DiazymeDZ042A-CON2016-11-03
00817089020535DiazymeDZ179A-CAL2016-11-03
00817089020542DiazymeDZ179A-CON2016-11-03
00817089020627DiazymeDZ147A-CAL2016-11-03
00817089020634DiazymeDZ147A-CON2016-11-03
00817089020689DiazymeDZ768A-CAL2016-11-03
00817089020696DiazymeDZ768A-CON2016-11-03
00817089020863DiazymeDZ141A-CAL2016-11-03

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
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
00630414964157IMMULITE®/IMMULITE® 1000 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