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Whole Blood Hemoglobin Determination

FDA product code KHG · Class 2 · Hematology

35
Registered devices
5
Adverse events
1
Recalls
39
510(k) clearances

Devices with this code

Hemo Control — EKF-diagnostic GmbHHemo Control Hemoglobin Microcuvette — EKF-diagnostic GmbHHemoglobin G6PDH Intermediate Control — ANALYTICAL CONTROL SYSTEMS INCPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDHemoglobin AD Control — ANALYTICAL CONTROL SYSTEMS INCHemoglobin A2 Elevated Control — ANALYTICAL CONTROL SYSTEMS INCPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDHemoglobin AS Control — ANALYTICAL CONTROL SYSTEMS INCHemoglobin AE Control — ANALYTICAL CONTROL SYSTEMS INCHemoglobin Total Normal Control — ANALYTICAL CONTROL SYSTEMS INCPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDHemoglobin G6PDH Normal Control — ANALYTICAL CONTROL SYSTEMS INCTrinity Biotech — CLARK LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.Hemoglobin F Abnormal Control — ANALYTICAL CONTROL SYSTEMS INCHemoglobin NAFSC Control — ANALYTICAL CONTROL SYSTEMS INCAdd Pack Hemo Control DM — EKF-diagnostic GmbHHemoglobin AC Control Powder — ANALYTICAL CONTROL SYSTEMS INCAIMSTRIP HEMOGLOBIN STARTER KIT 200 — GERMAINE LABORATORIES, INCHemoglobin FAS Control — ANALYTICAL CONTROL SYSTEMS INCHemoglobin F Normal Control — ANALYTICAL CONTROL SYSTEMS INCHemoglobin AC Control — ANALYTICAL CONTROL SYSTEMS INCAIMSTRIP HEMOGLOBIN TEST COMBO — GERMAINE LABORATORIES, INC

Recent recalls

DateFirmReason
2005-12-09Roche Diagnostics Corp.Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb,

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.