Devices

Micro Plate EIA Oral Fluid Cutoff Calibrator

Model / Serial
Product number 61454. Lot number 6604282, 6604835, 6606584, 6606590, and 6606035
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution --- USA including states of AZ, CA, CT, DE, FL, GA, ID, KS, KY, MA, MD, MI, NC, NH, NV, NY, PA, VA, and WY, and countries of United Kingdom, Italy, Germany, and Canada.
Product Description
Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit.
Manufacturer
OraSure Technologies, Inc.
1 Event
- Recall of Micro Plate EIA Oral Fluid Cutoff Calibrator

Manufacturer

OraSure Technologies, Inc.

Manufacturer Address
OraSure Technologies, Inc., 1745 Eaton Ave, Bethlehem PA 18018-1769
Manufacturer Parent Company (2017)
OraSure Technologies, Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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