EATONTOWN, NEW JERSEY – 01-23-2019 (PRDistribution.com) — FDA 510(k) clearance allows Immunostics to market and sell its new hemoglobin analyzer
January 22, 2019 — Immunostics, Inc., a subsidiary of Boditech Med Inc., a global leader in point?of?care testing, 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 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).
The portable analyzer also features:
- Fast Results – Simple, accurate, reliable results in 3 seconds
- Small Sample Size – Only requires a fingerstick of blood
- Reagent-free Microcuvettes – Microcuvettes unaffected by moisture or temperature with a shelf life up to 2 years
- Data Storage – Recalls the last 1,000 test results
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 capability ensures that we will offer high quality and cost competitive products to US customers.”
In the U.S., Immunostics, Inc. will distribute Hemochroma PLUS through our current distribution channel partners, with the potential to expand distribution in the future.
About Immunostics, Inc.
Immunostics develops, manufactures and sells FDA-approved microbiological, serological and immunological diagnostic kits and reagents. The Company’s flagship products test for fecal occult blood as an indicator of the presence of colorectal cancer or other gastro-intestinal disorders. Immunostics holds several U.S. and international patents and trademarks.
About Boditech Med
Boditech Med markets its own brand of point-of-care diagnostic products to more than 70 countries. Headquartered in Seoul, South Korea, Boditech is a public company listed on the KOSDAQ. A world leader in in vitro diagnostics, Boditech Med has a product portfolio of 33 diagnostic reagents.
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