Home › Device types › GHR
Reagent, Platelet Aggregation
FDA product code GHR · Class 2 · Hematology
12
Registered devices
1
Adverse events
2
Recalls
11
510(k) clearances
Devices with this code
Plateletworks Arachidonic Acid Kit — HELENA LABORATORIES CORPORATIONRistocetin (7.5 mg/vial) — TCOAG IRELAND LIMITEDCHRONO-PAR — CHRONO-LOG CORPCHRONO-PAR — CHRONO-LOG CORPCHRONO-PAR — CHRONO-LOG CORPCHRONO-PAR — CHRONO-LOG CORPPlatelet Aggregation Kit — HELENA LABORATORIES CORPORATIONCollagen Reagent — HELENA LABORATORIES CORPORATIONAdenosine Diphosphate (ADP) — TCOAG IRELAND LIMITEDEpinephrine Reagent — HELENA LABORATORIES CORPORATIONADP Reagent — HELENA LABORATORIES CORPORATIONCHRONO-PAR — CHRONO-LOG CORP
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-05-23 | Helena Laboratories, Corp. | Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particul |
| 2018-05-23 | Helena Laboratories, Corp. | Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particula |
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