Immunostics, Inc. announced today it has received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the United States Food and Drug Administration (FDA) for the Hemochroma PLUS hemoglobin analyzer.
The Hemochroma PLUS provides clinicians with lab accuracy cost effective, quantitative method for measurement of hemoglobin and hematocrit using it’s specially designed microcuvettes within 3 seconds of being inserted for analysis. This ensures immediate results for patient health checks and anemia screening at the point-of-care testing (POCT). Adam Choe, CEO of Immunostics, says “the Hemochroma PLUS analyzer has successfully been sold in over 50 countries globally and is one of the world’s most reliable hemoglobin analyzers and has become the standard in POCT. We are focused on continuing to deliver innovative products and are confident our Hemochroma PLUS offering will improve patient care. Our world class manufacturing ensures that we offer high quality and cost competitive products to US customers.” Immunostics, Inc. will distribute Hemochroma PLUS through our current distribution channel partners, with potential to expand distribution in the future.