Amdinocillin 10 Mcg Sensi-Disc

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K850357 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the Amdinocillin 10mcg Sensi-Disc used for?

  The Amdinocillin 10mcg Sensi-Disc is designed for in vitro antimicrobial susceptibility testing in microbiology laboratories. It delivers a standardized 10 microgram dose of amdinocillin to determine whether bacteria are sensitive or resistant to this antibiotic. This helps clinicians select appropriate treatments for infections.

• How is the Amdinocillin 10mcg Sensi-Disc supplied and stored?

  The disc is supplied sterile and packaged individually to maintain integrity. Storage must follow standard laboratory protocols for antimicrobial susceptibility discs. Avoid exposure to moisture, extreme temperatures, or contamination, as these can compromise test accuracy.

• Is the Amdinocillin 10mcg Sensi-Disc intended for single-use or reuse?

  This disc is explicitly intended for single-use only. Reusing antimicrobial susceptibility discs can introduce contamination or inaccurate dosing, leading to unreliable test results. Each disc is designed to provide one precise measurement per test.

• Does the Amdinocillin 10mcg Sensi-Disc require any special handling or regulatory compliance?

  The disc is regulated under FDA 510(k) clearance (K850357) as a Class II medical device, ensuring it meets established safety and performance standards. No additional handling beyond standard microbiology lab practices is required, and it does not have MRI safety considerations.

• What distinguishes this disc from other antimicrobial susceptibility test discs?

  The Amdinocillin 10mcg Sensi-Disc is specifically formulated to deliver a precise 10 microgram dose of amdinocillin, distinguishing it from discs with different antibiotic concentrations or formulations. This standardized dosing ensures consistent and reproducible results for qualitative susceptibility testing of bacteria.