Uniscept(Tm)

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

Manual antimicrobial susceptibility test systems

PMA Number

P830028 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

APPR Approved

PMA Supplement

S001

• Api 50 E

  Class I

  FDA 510(k) K770989 Active Cleared 29 Jun 1977

• Aso Sure Plus

  Class I

  FDA 510(k) K820786 Active Cleared 8 Apr 1982

• Api 20GP

  Class I

  FDA 510(k) K830525 Active Cleared 18 May 1983

• Aladin (TM)

  Class II

  FDA 510(k) K865062 Active Cleared 25 Mar 1987

• Artap Arterial Blood Sampling Device

  Class I

  FDA 510(k) K843360 Active Cleared 31 Oct 1984

• Referee Bft Blood for Tonometry

  Class I

  FDA 510(k) K792447 Active Cleared 27 Dec 1979

See all devices from Analytical Products, Inc. →

• What types of bacterial isolates can the Uniscept™ system test for antimicrobial sensitivity, and how does it help in treatment decisions?

  The Uniscept™ Manual Antimicrobial Susceptibility Test System is designed to evaluate bacterial isolates against a range of antibiotics, helping clinicians determine which antimicrobial agents will be most effective against specific infections. By identifying bacterial sensitivity patterns, it aids in selecting appropriate treatment regimens for infectious diseases, reducing trial-and-error prescribing and improving patient outcomes.

• Is the Uniscept™ system intended for single-use or repeated use in a clinical lab, and what does this mean for cost management?

  The Uniscept™ system is supplied as a manual test kit and requires sterile components for accurate results, which implies it is intended for single-use per test. This design ensures reliability and reduces cross-contamination risks, but labs should account for ongoing supply costs as each test requires a new kit. The system is optimized for routine microbiological testing in clinical labs, where frequent testing is standard.

• How is the Uniscept™ system regulated by the FDA, and what does this mean for laboratories using it?

  The Uniscept™ system is regulated under the FDA’s Premarket Approval (PMA) process, with PMA number P830028. This classification (Class II) ensures it meets stringent standards for antimicrobial susceptibility testing, providing confidence in its accuracy and reliability for clinical decision-making. Laboratories using it must adhere to FDA guidelines for microbiological testing, including proper handling and documentation, as the system is intended exclusively for use in clinical microbiology labs.

• What product codes (e.g., JWY) correspond to the Uniscept™ system, and how do they relate to its regulatory compliance?

  The Uniscept™ system is distributed under product code JWY, which aligns with FDA’s classification for manual antimicrobial susceptibility test systems (device class 2, regulation number 866.1640). This code ensures the system meets the specific requirements for microbiological testing, including sterility and performance standards, while also facilitating proper inventory and compliance tracking in laboratories.