Binas Luteinizing Hormone IRMA Test Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K883306 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Binas Luteinizing Hormone IRMA Test Kit used for?

  The Binas Luteinizing Hormone IRMA Test Kit is used for the measurement of luteinizing hormone levels in clinical chemistry laboratories.

• Is the Binas Luteinizing Hormone IRMA Test Kit supplied sterile?

  The device data does not specify if the kit is supplied sterile, but it is designed for in vitro diagnostic use.

• What is the regulatory classification of the Binas Luteinizing Hormone IRMA Test Kit?

  The Binas Luteinizing Hormone IRMA Test Kit is classified as a Class II medical device and received FDA 510(k) clearance under K883306.