Api Uniscept Mic 100ul

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K844159 ↗

FDA Product Code

LTW

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Api 50 E

  Class I

  FDA 510(k) K770989 Active Cleared 29 Jun 1977

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  Class I

  FDA 510(k) K820786 Active Cleared 8 Apr 1982

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  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

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  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 is the API Uniscept MIC 100µL used for?

  The API Uniscept MIC 100µL is designed for antimicrobial susceptibility testing in clinical microbiology laboratories. It measures the minimum inhibitory concentration (MIC) of antibiotics against isolated bacterial strains, helping determine whether a bacterium is resistant or susceptible to specific antimicrobial agents. This information directly supports clinical decision-making in managing infectious diseases by guiding appropriate antibiotic therapy.

• Is the API Uniscept MIC 100µL card sterile?

  No, the API Uniscept MIC 100µL card is supplied as a non-sterile test card. It is intended for single-use in controlled laboratory environments where sterility is not required for the testing procedure itself, but standard microbiological practices should still be followed to prevent contamination.

• Can the API Uniscept MIC 100µL card be reused?

  No, the API Uniscept MIC 100µL card is explicitly designed for single-use only. Reusing the card could compromise the accuracy of MIC measurements and introduce cross-contamination risks, potentially leading to unreliable results and compromising patient safety.

• What regulatory approval does the API Uniscept MIC 100µL hold?

  The API Uniscept MIC 100µL received FDA 510(k) clearance under the classification of Substantially Equivalent (SESE) in 1984, with clearance number K844159. This classification indicates that the device is deemed substantially equivalent to a legally marketed predicate device in terms of technology and safety. The device falls under FDA regulation number 866.1640 and product code LTW.

• How should the API Uniscept MIC 100µL card be stored?

  While specific storage instructions are not detailed in the provided data, antimicrobial susceptibility test cards like the API Uniscept MIC 100µL are generally recommended to be stored in a cool, dry place, protected from direct sunlight and extreme temperatures. Proper storage ensures the integrity of the card’s antimicrobial agents and prevents degradation, which could affect test accuracy. Always refer to the manufacturer’s instructions for precise storage guidelines.