FDA.reportPublic FDA data

Adenosine Diphosphate (ADP)

Primary DI
15391521420067
Brand
Adenosine Diphosphate (ADP)
Company
TCOAG IRELAND LIMITED
Model
50704
Published
2016-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GHRReagent, Platelet Aggregation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHRReagent, Platelet AggregationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910286000PLATELET AGGREGATION REAGENTSMedical Diagnostic Technologies, Inc.1991-03-19GHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15391521420067PrimaryGS10
05391521420060Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1539152142006715391521420067
05391521420060053915214200605391521420060

GMDN Terms#

Term, Definition table
TermDefinition
Platelet aggregation study IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents and a nephelometry/turbidimetry method. Platelet aggregation agents used may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985039126
Device count
3
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
05391521421029Destiny PlusH01000P2016-09-12
05391521421081Destiny MAX AnalyzerM010002016-09-12
15391521421309DT WashDTW2019-06-28
15391521421729DT FluidDTF2019-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811476010048CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
00811476010055CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
00811476010062CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
00811476010086CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
00811476010147CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
15391521420081Ristocetin (7.5 mg/vial)TCOAG IRELAND LIMITEDGHR2016-09-12
M52553660ADP ReagentHELENA LABORATORIES CORPORATIONGHR2016-09-07
M52553670Epinephrine ReagentHELENA LABORATORIES CORPORATIONGHR2016-09-07
M52553680Collagen ReagentHELENA LABORATORIES CORPORATIONGHR2016-09-07
M52553690Platelet Aggregation KitHELENA LABORATORIES CORPORATIONGHR2016-09-07
M52558640Plateletworks Arachidonic Acid KitHELENA LABORATORIES CORPORATIONGHR2016-09-07