FDA.reportPublic FDA data

Platelet aggregation study IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.
GUDID devices
51
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00856893004010AggreDYNE AA AssayAGGREDYNE, INC.A-1002019-01-01
04589448510082PL ChipZACROS CORPORATIONN/A2024-12-12
10812747018050TEG HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-0142017-03-13
10812747018067TEG HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-0152017-03-13
10812747018074TEG HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-0162017-03-13
10812747018319TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-614-US2017-04-25
10812747018371Hemostasis SystemHAEMONETICS CORPORATION07-615-US2017-07-11
M52551990Helena RistocetinHELENA LABORATORIES CORPORATION51992016-09-07
M52553640Arachidonic AcidHELENA LABORATORIES CORPORATION53642016-09-07
M52553660ADP ReagentHELENA LABORATORIES CORPORATION53662016-09-07
M52553670Epinephrine ReagentHELENA LABORATORIES CORPORATION53672016-09-07
M52553680Collagen ReagentHELENA LABORATORIES CORPORATION53682016-09-07
M52553690Platelet Aggregation KitHELENA LABORATORIES CORPORATION53692016-09-07
M52558500Plateletworks Combo-15 KitHELENA LABORATORIES CORPORATION58502016-09-07
M52558520Plateletworks Combo-25 KitHELENA LABORATORIES CORPORATION58522016-09-07
M52558540Plateletworks Combo-10 KitHELENA LABORATORIES CORPORATION58542016-09-07
M52558600Plateletworks ADP KitHELENA LABORATORIES CORPORATION58602016-09-07
M52558620Plateletworks Collagen KitHELENA LABORATORIES CORPORATION58622016-09-07
M52558640Plateletworks Arachidonic Acid KitHELENA LABORATORIES CORPORATION58642016-09-07
04589448510037PL Chip for T-TAS 01ZACROS CORPORATIONN/A2024-12-12
14589448510089PL ChipZACROS CORPORATIONN/A2024-12-12
10711234150016VerifyNow Platelet Reactivity TestACCRIVA DIAGNOSTICS HOLDINGS, INC.850532016-09-22
10711234150023VerifyNow Platelet Reactivity TestACCRIVA DIAGNOSTICS HOLDINGS, INC.85053-102016-09-22
10711234150030VerifyNow Platelet Reactivity TestACCRIVA DIAGNOSTICS HOLDINGS, INC.853102016-09-22
10711234150078VerifyNow Platelet Reactivity TestACCRIVA DIAGNOSTICS HOLDINGS, INC.852252016-09-22
G0561009700AggRecetin Bio/Data Corporation1.0-1.5 mg/mL2022-03-23
G0561012971Arachidonic AcidBio/Data Corporation1012972022-03-23
G0561013111EpinephrineBio/Data Corporation1013112022-03-23
G0561013121ADPBio/Data Corporation1013122022-03-23
G0561015621CollagenBio/Data CorporationCalf Skin Type 12022-03-23
00817869020014Slide Platelet Aggregation Test ReagentANALYTICAL CONTROL SYSTEMS INCCR-121-12019-01-31
00856893004027AggreguideAGGREDYNE, INC.A-1002019-09-23
20812747018101TEG5000 HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-0402017-04-25
20812747018118TEG5000 HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-0412017-04-25
20812747018125TEG5000 HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-0422017-04-25
00842768003691Dade® PFA Trigger SolutionSiemens Healthcare Diagnostics Products GmbH104457012016-09-24
20856893004014AggreDYNE AA AssayAGGREDYNE, INC.A-1002019-01-01
00811476010000Chrono-logCHRONO-LOG CORP299-12016-10-11
00811476010017Chrono-logCHRONO-LOG CORP299-42016-10-11
00811476010048CHRONO-PARCHRONO-LOG CORP3842016-10-11
00811476010055CHRONO-PARCHRONO-LOG CORP3852016-10-11
00811476010062CHRONO-PARCHRONO-LOG CORP3872016-10-11
00811476010079CHRONO-PARCHRONO-LOG CORP3952016-10-11
00811476010086CHRONO-PARCHRONO-LOG CORP3962016-10-11
00811476010123Chrono-logCHRONO-LOG CORP299-22016-10-11
00811476010130Chrono-logCHRONO-LOG CORP299-52016-10-11
00811476010147CHRONO-PARCHRONO-LOG CORP3862016-10-11
00811476010154CHRONO-PARCHRONO-LOG CORP3902016-10-11
00811476010161Chrono-log CHRONO-LOG CORP2992016-10-11
00811476010291Chrono-logCHRONO-LOG CORP299-32016-10-11
00811476010307CHRONO-PARCHRONO-LOG CORP3932016-10-11