FDA.reportPublic FDA data

Diazyme

Primary DI
00817089020542
Brand
Diazyme
Company
DIAZYME LABORATORIES, INC.
Model
DZ179A-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
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
GHHFibrin Split Products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlHematology2
GHHFibrin Split ProductsHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112120000DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme Laboratories2013-01-24GHH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817089020542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089020542008170890205428170890205420817089020542

GMDN Terms#

Term, Definition table
TermDefinition
D-dimer IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of D-dimer protein 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
00817089020627DiazymeDZ147A-CAL2016-11-03
00817089020634DiazymeDZ147A-CON2016-11-03
00817089020689DiazymeDZ768A-CAL2016-11-03
00817089020696DiazymeDZ768A-CON2016-11-03
00817089020863DiazymeDZ141A-CAL2016-11-03
00817089022539DiazymeDZ152A-CON2023-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414634029INNOVANCE D-Dimer 2.0Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414634210INNOVANCE D-Dimer 2.0 DiluentSiemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 3Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 2Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 1Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 1Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414656014INNOVANCE D-Dimer 2.0Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 2Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 3Siemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENTSiemens Healthcare Diagnostics Products GmbHDAP2026-08-19
00816870023878D-Dimer AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DAP2024-09-13
00816870023885D-Dimer AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DAP2024-09-13
00816870023892D-Dimer AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DAP2024-09-13
00816870023908D-Dimer AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DAP2024-09-13
00630414639666INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00842768019265INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640181INNOVANCE D-Dimer ControlsSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640488INNOVANCE D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640501INNOVANCE D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
05056080501666Thrombo-Wellcotest Glycine SalineREMEL EUROPE LIMITEDDAP2021-07-21
07613336133651Tina-quant D-DimerRoche Diagnostics GmbHGHH2020-12-04
08426951391615HemosIL D-Dimer HS 500INSTRUMENTATION LABORATORY COMPANYDAP2019-06-10
00895160002502Fluoro-CheckTM D-DimerNANO-DITECH CORPORATIONDAP2019-05-24
30014613337959TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
30014613338000TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
30014613338017TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
00817089020528DiazymeDIAZYME LABORATORIES, INC.GHH2016-11-03
00817089020535DiazymeDIAZYME LABORATORIES, INC.GHH2016-11-03
00893038002326Alere Triage®Alere San Diego, Inc.DAP2016-09-26
00899722002733Alere Triage®Alere San Diego, Inc.DAP2016-09-26