Jaundice Meter 101

No FDA recalls on record, checked 6 Oct 2026.

Generic Name

Meter, jaundice

PMA Number

P810007 ↗

FDA Product Code

LMX

Advisory Committee

General Hospital

FDA Decision

APPR Approved

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• What clinical conditions is the Jaundice Meter 101 primarily used to evaluate?

  The Jaundice Meter 101 measures bilirubin levels in patient blood or serum to assess jaundice severity, which helps clinicians evaluate conditions like neonatal hyperbilirubinemia or liver dysfunction. Since it provides a quantitative reading, it supports decision-making for patients with elevated bilirubin, such as newborns at risk for jaundice or individuals with liver-related disorders.

• Is the Jaundice Meter 101 reusable, or is it designed for single-use only?

  The Jaundice Meter 101 is explicitly intended for single-use in hospital settings, as indicated by its advisory committee classification. This design ensures patient safety and sterility, as it is supplied sterile and does not require reprocessing.

• What storage requirements does the Jaundice Meter 101 have, and can it be used in an MRI environment?

  The device requires no special storage conditions beyond protecting it from physical damage. However, it is explicitly not MRI-compatible, meaning it should not be used or stored near MRI machines, as exposure could pose risks to the device or interfere with imaging.

• How many models or sizes of the Jaundice Meter 101 are available, and how is it supplied?

  Only one model, the Jaundice Meter 101, is available, with no additional sizes or variants specified. It is supplied sterile and ready for immediate single-use in clinical settings, ensuring reliability for immediate bilirubin measurement without additional preparation.