Reagent, Platelet Aggregation
Hematology · 21 CFR 864.5700
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Helena Laboratories, Corp.Open, ClassifiedUnknown
Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen
Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.
Z-0536-2020 · View FDA record ↗ - Helena Laboratories, Corp.Open, ClassifiedUnknown
Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.
Z-0537-2020 · View FDA record ↗
Registered firms
8 firms currently registered for this product code
510(k) clearances
11 clearances for this product code
- Helena LaboratoriesFeb 23, 2007
K061991 · PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
- Helena LaboratoriesSep 8, 1995
K952252 · ADP REAGENT, MODIFIED
- Chrono-Log Corp.Aug 26, 1992
K922800 · PLATELET AGGREGATION REAGENTS
- Helena LaboratoriesMay 20, 1991
K910800 · ADP REAGENT
- Helena LaboratoriesMay 20, 1991
K910706 · COLLAGEN REAGENT CAT. NO. 5368
- Helena LaboratoriesMay 20, 1991
K910680 · EPINEPHRINE REAGENT, CAT. NO. 5367
- Medical Diagnostic Technologies, Inc.Mar 19, 1991
K910286 · PLATELET AGGREGATION REAGENTS
- Medical Diagnostic Technologies, Inc.Mar 27, 1990
K900792 · RISTOCETIN