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REAADS Coagulation Control 2

CORGENIX MEDICAL CORPORATION · Model 702-001 · UDI-DI 00855360006250

GGC Prescription
1
510(k) clearances
1
Adverse events
0
Recalls
21
Facilities

Description

REAADS Coagulation Control 2 (CC-2) ) is an assayed control plasma in coagulation studies for In Vitro Diagnostic Use. PRINCIPLE OF THE PROCEDURE Coagulation Control 2 is tested in the same manner as citrated patient plasma samples to assess the performance of each assay run, for the parameters. Testing variables in each laboratory, including equipment, reagents, and technique may influence control recovery. Although an expected range is provided for each parameter, laboratories should establish their own expected range for their particular instrument-reagent system. Refer to Package Insert.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.