FDA.reportPublic FDA data

HemosIL D-Dimer

Primary DI
08426950060451
Brand
HemosIL D-Dimer
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00020008500
Catalog number
00020008500
Device description
HemosIL D-Dimer
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950060451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950060451084269500604518426950060451

GMDN Terms#

Term, Definition table
TermDefinition
D-dimer IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen, using an agglutination method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Unopened reagents and calibrator are stable until the expiration date shown on the vial when stored at 2-8°C.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-678-0710techsupport@werfen.com
1-800-678-0710techsupport.na@werfen.com

Regulatory Flags#

DUNS number
557223252
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
08426950071068HemosIL Normal Control ASSAYED00020003110000200031102016-09-23
08426950088646GEM Check Coag Control-Abnormal for ACT-LR06260060200062600602002016-09-23
08426950088653GEM Check Coag Control-Abnormal for ACT06260060300062600603002016-09-23
08426950452683GEM Check Coag Control-Normal for Citrate PT06260061100062600611002016-09-23
08426950452713GEM Check Coag Control-Abnormal for Citrate PT06260061400062600614002016-09-23
08426950452744GEM Check Coag Control-Normal for ACT06260060500062600605002016-09-23
08426950452751GEM Check Coag Control-Normal for ACT-LR06260060600062600606002016-09-23
08426950573401HemosIL Routine Control Level 300020005800000200058002016-09-23
08426950660668HemosIL Abnormal Control 200020014000000200140002016-09-23
08426950078982HemosIL Low Abnormal Control ASSAYED00020003210000200032102016-09-23
08426950078999HemosIL High Abnormal Control ASSAYED00020003310000200033102016-09-23
08426950087595HemosIL Calibration Plasma00020003700000200037002016-09-23
08426950088639GEM Check Coag Control-Abnormal for APTT06260060100062600601002016-09-23
08426950088912Coatest APCR Control Plasma Level 182 2650 6382 2650 632016-09-23
08426950088929Coatest APCR Control Plasma Level 282 2668 6382 2668 632016-09-23
08426950442189HemosIL Special Test Control Level 200020012000000200120002016-09-23
08426950452690GEM Check Coag Control-Normal for APTT06260061600062600616002016-09-23
08426950452706GEM Check Coag Control-Abnormal for PT06260061700062600617002016-09-23
08426950452737GEM Check Coag Control-Normal for PT06260060400062600604002016-09-23
08426950453062HemosIL Special Test Control Level 100020011000000200110002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00817089020542DiazymeDIAZYME LABORATORIES, INC.DAP2016-11-03
00893038002326Alere Triage®Alere San Diego, Inc.DAP2016-09-26
00899722002733Alere Triage®Alere San Diego, Inc.DAP2016-09-26
00899722002740Alere Triage®Alere San Diego, Inc.DAP2016-09-26
B1761070Antiserum to Human FibrinogenKENT LABORATORIES INCDAP2016-09-24
05056080500041NAREMEL EUROPE LIMITEDDAP2016-09-24
05056080500058NAREMEL EUROPE LIMITEDDAP2016-09-24
00842768003967Dade® DIMERTEST® Latex AssaySiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768003974Dade® DIMERTEST® Latex BeadsSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768004575Acute Care™ D-DIMER CalPakSiemens Healthcare Diagnostics Inc.DAP2016-09-24
00842768004582Stratus® CS Acute Care™ DDMR DilPakSiemens Healthcare Diagnostics Inc.DAP2016-09-24
00842768022814INNOVANCE® D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768022821INNOVANCE® D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768023668INNOVANCE® D-Dimer ControlsSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768027611INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24