Search Results
Found 2 results
510(k) Data Aggregation
K Number
K993332Device Name
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
Manufacturer
GRADIPORE LTD.
Date Cleared
2000-02-16
(135 days)
Product Code
GGC
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
GRADIPORE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GradiPlasma LA High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore. GradiPlasma LA Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore.
Device Description
GradiPlasma LA High and Low are preparations of fresh human citrated plasma with added buffers and stabilizers, for in vitro diagnostic use. The controls are prepared from patients diagnosed with Lupus Anticoagulant and lyophilized in two levels (High and Low) and two volumes (0.5ml and 1.0ml).
Ask a Question
K Number
K992456Device Name
GRADILEIDEN V TEST
Manufacturer
GRADIPORE LTD.
Date Cleared
1999-12-21
(151 days)
Product Code
GGW
Regulation Number
864.7925Why did this record match?
Applicant Name (Manufacturer) :
GRADIPORE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GradiLeiden V is a simple functional clotting test system intended for screening of resistance to Activated Protein C in plasma from individuals with the Factor V (Leiden) defect. It can also be performed on plasma from patients on stabilized oral anticoagulant or heparin therapy.
Device Description
The GradiLeiden V Test is a lyophilized paired reagent containing 5 vials of whole diluted Agkistrodon contortrix venom and 5 vials of phospholipid rich Russell's Viper Venom time reagent.
Ask a Question
Page 1 of 1