Lincocin Susceptibility Pwd

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Susceptibility test powders, antimicrobial

PMA Number

N61034 ↗

FDA Product Code

JTT

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

APRL

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See all devices from The Upjohn Co. →

• What is the Linocin Susceptibility Powder used for in a clinical setting?

  The Linocin Susceptibility Powder is designed for laboratory use to test how effective lincomycin is against specific bacterial samples. By measuring microbial resistance patterns, it helps clinicians determine the best antimicrobial treatment options for patients, ensuring targeted and effective therapy.

• Is the Linocin Susceptibility Powder intended for single-use or repeated use?

  The Linocin Susceptibility Powder is explicitly labeled as a single-use reagent. This ensures accuracy and sterility in antimicrobial susceptibility testing, as repeated use could compromise the integrity of the results or introduce contamination.

• How should the Linocin Susceptibility Powder be stored to maintain its effectiveness?

  Since it is a sterile microbiological reagent, storage must follow standard microbiological protocols to preserve sterility and accuracy. While specific storage conditions aren’t detailed here, it should be kept in a clean, dry environment away from direct light and extreme temperatures, as recommended for antimicrobial susceptibility test powders.

• What regulatory pathway does the Linocin Susceptibility Powder follow, and why?

  The Linocin Susceptibility Powder follows the FDA Premarket Approval (PMA) pathway, indicated by its PMA number (N61034). This route is typically required for devices classified as Class II under FDA regulations (866.1640), ensuring that its safety and effectiveness for determining antimicrobial resistance are thoroughly evaluated before clinical use.

• Can this powder be used across different types of clinical microbiology laboratories?

  Yes, the Linocin Susceptibility Powder is intended for use in clinical laboratories specializing in microbiology, as indicated by its classification and regulatory designation. Its standardized design ensures compatibility with laboratory protocols for testing bacterial susceptibility to lincomycin, making it suitable for general microbiology applications.