Enzyme-Immunoassay (Rubella Antibodies)

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K801098 ↗

FDA Product Code

GOL

Device Class

Class II

Regulation

21 CFR Part 866.3510

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Flow Laboratories, Inc. →

• What clinical purpose does this enzyme-immunoassay kit serve in a lab setting?

  This enzyme-immunoassay kit detects and quantifies rubella antibodies in serum or plasma samples. It helps clinicians determine whether a patient has been previously infected with rubella or has developed immunity, which is critical for diagnosing rubella infection or assessing immunity status in individuals.

• Is this test kit reusable, or is it meant for single-use only?

  The kit is explicitly designed for single-use only. It is supplied as a diagnostic kit intended to be used once per test, ensuring accuracy and preventing cross-contamination between samples.

• What storage conditions are required for this enzyme-immunoassay kit?

  The kit does not require special storage conditions beyond standard refrigeration. It should be stored between 2°C and 8°C to maintain its integrity and performance for diagnostic testing.

• How was this device’s regulatory pathway determined, and what does that mean for its use?

  This device received FDA 510(k) clearance under the Microbiology advisory committee in 1980, with a determination of *substantially equivalent* to a predicate device. This means the device was reviewed as a Traditional 510(k) submission and deemed comparable to existing technology in its category, allowing it to be legally marketed for its intended use in clinical microbiology labs.

• Where is this device manufactured, and who is the applicant responsible for its regulatory submission?

  The device is manufactured by Flow Laboratories, Inc., which is also the applicant responsible for the FDA submission. The manufacturer’s address listed in the records is 803 N. Front St. Suite 3, McHenry, IL 60050, USA.