Salmonella I.D.

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K821338 ↗

FDA Product Code

GRM

Device Class

Class II

Regulation

21 CFR Part 866.3550

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• 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 is the Salmonella I.D. antisera reagent used for?

  The Salmonella I.D. is a diagnostic reagent designed specifically for identifying *Salmonella* species in clinical microbiology laboratories. It aids in confirming the presence of *Salmonella* bacteria through serological testing, which is critical for accurate bacterial identification and patient diagnosis. This reagent supports routine microbiological workflows where rapid and reliable detection of *Salmonella* is essential.

• How is the Salmonella I.D. supplied and what are its handling requirements?

  The Salmonella I.D. is supplied as a single-use reagent, ensuring sterility and consistency for each test. Since it is intended for microbiological use, it must be handled under sterile conditions to prevent contamination. Laboratories should follow standard microbiological reagent protocols for storage, including maintaining proper temperature and avoiding exposure to light or moisture, to preserve its efficacy and reliability in bacterial identification.

• Is the Salmonella I.D. reusable or intended for single-use only?

  The Salmonella I.D. is explicitly designed for single-use only. This classification ensures that each reagent remains uncontaminated and maintains its accuracy for identifying *Salmonella* species. Reusing microbiological reagents can introduce cross-contamination risks, compromising test results and potentially leading to false negatives or positives. Adhering to single-use guidelines is essential for maintaining diagnostic integrity.

• What regulatory approvals does the Salmonella I.D. hold?

  The Salmonella I.D. holds FDA 510(k) clearance under the classification code K821338, confirming its substantial equivalence to a predicate device. This clearance falls under the FDA’s product code GRM and regulatory category 866.3550, categorizing it as a Class II medical device for microbiological testing. The clearance ensures compliance with U.S. regulatory standards for diagnostic reagents used in clinical microbiology.

• What storage conditions are recommended for the Salmonella I.D.?

  While specific storage conditions are not detailed in the provided data, the Salmonella I.D. must be stored and handled according to standard microbiological reagent protocols. This typically includes maintaining the reagent in a clean, dry environment at room temperature (unless otherwise specified) and protecting it from light and contamination. Laboratories should refer to the manufacturer’s instructions for precise storage guidelines to ensure optimal performance and sterility.