Biosyn , Ltd.

Biosyn, Ltd. manufactures the GASTRIN EIA Model 06B-555017, which is an enzyme immunoassay (EIA) test kit. This device is specifically designed for measuring gastrin levels in serum or plasma samples, helping to support clinical laboratory diagnostics for conditions like Zollinger-Ellison syndrome.

Biosyn, Ltd. is based in the United States. The company’s location is relevant for understanding regulatory oversight and compliance, as it operates under the jurisdiction of the FDA.

The GASTRIN EIA Model 06B-555017, the only listed device from Biosyn, Ltd., is classified as a Class I medical device under FDA regulations. Class I devices are generally considered to pose the lowest risk and often require less stringent premarket review, though compliance with quality system regulations still applies.

Biosyn, Ltd.’s GASTRIN EIA Model 06B-555017 is listed in the FDA’s 510(k) clearance database, indicating it has undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device. This registry helps healthcare providers and regulators verify the device’s regulatory status.

The Class I classification means the device is subject to general controls (e.g., good manufacturing practices) but does not require additional premarket approval or postmarket surveillance beyond standard compliance. Users should note this classification when assessing risk, as it implies lower regulatory scrutiny compared to higher-risk devices, though clinical performance and accuracy remain critical for diagnostic reliability.