FDA.reportPublic FDA data

Destiny Plus

Primary DI
05391521421029
Brand
Destiny Plus
Company
TCOAG IRELAND LIMITED
Model
H01000P
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JPASystem, Multipurpose For In Vitro Coagulation Studies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391521421029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391521421029053915214210295391521421029

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation analyser IVD, laboratory, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985039126
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15391521420630TriniCHECK Level 1T41112019-06-28
15391521420647TriniCHECK Level 2T41122019-06-28
15391521420654TriniCHECK Level 3T41132019-06-28
15391521420708TriniCAL™ Reference PlasmaT51022016-09-12
15391521421101TriniCHECK™ Abnormal controlT41042016-09-12
05391521420718TriniVerical™ T51032016-09-12
05391521420534TriniCHROM™ Antithrombin IIaT26022016-09-12
15391521420234TriniCLOT™ PT HTF 20 mLT11012016-09-12
15391521420241TriniCLOT™ PT HTF 6 mLT11022016-09-12
15391521420340TriniCLOT™ Automated aPTT 3 mLT12062016-09-12
15391521420661TriniCHECK™ Lupus Positive ControlT42032016-09-12
15391521420777TriniCHECK™ D-Dimer 1T43032016-09-12
15391521421125Destiny System FluidDSF2016-09-12
05391521420282TriniCLOT™ PT Excel 6 mLT11062016-09-12
05391521420305TriniCLOT™ aPTT S 3 mLT12022016-09-12
05391521420541TriniCHROM™ Antithrombin XaT26032016-09-12
05391521421081Destiny MAX AnalyzerM010002016-09-12
15391521421309DT WashDTW2019-06-28
15391521421729DT FluidDTF2019-06-28
15391521420067Adenosine Diphosphate (ADP)507042016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000558185CLOTtrac™MEDTRONIC, INC.JPA2026-02-22
00763000558291RACTMEDTRONIC, INC.JPA2026-02-22
20763000558189CLOTtrac™MEDTRONIC, INC.JPA2026-02-22
20763000558295RACTMEDTRONIC, INC.JPA2026-02-22
04987562499700Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONJPA2025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONJPA2025-12-19
08426951011223HemosIL CL TriggersINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08426951326594HemosIL CL Rinse solutionINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08430793045476ACL TOP 970 CLINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08430793058322HemosIL CL Probe ConditionerINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
04987562499687Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
10812747018531Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
20812747018538Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
00630414639772Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00630414640563Calcium Chloride SolutionSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00842768018893Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00842768018916Calcium Chloride SolutionSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
04987562518654Automated Blood Coagulation Analyzer CS-5100SYSMEX CORPORATIONJPA2024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500SYSMEX CORPORATIONJPA2024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONJPA2024-02-22
00810149090622R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149091681R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092619R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092626R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092749R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149093258R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149095542R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149096969R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
G0561009910Tris Buffered SalineBio/Data CorporationJPA2023-08-30