GC Culture Medium

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

510(k) Number

K811281 ↗

FDA Product Code

JTY

Device Class

Class II

Regulation

21 CFR Part 866.2410

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Gc Ttansport System

  Class I

  FDA 510(k) K811284 Active Cleared 12 Jun 1981

• Selective Gc Culture Medium

  Class II

  FDA 510(k) K811282 Active Cleared 12 Jun 1981

• Jembec Transport System

  Class I

  FDA 510(k) K811283 Active Cleared 12 Jun 1981

• Disposable Urostomy Pouch

  Class I

  FDA 510(k) K850750 Active Cleared 23 May 1985

• Dispos. Drainabel Pouch for Ileostomy/Colostomy

  Class I

  FDA 510(k) K850751 Active Cleared 23 May 1985

• What is the GC Culture Medium specifically used for in a clinical setting?

  The GC Culture Medium is designed for the selective isolation and cultivation of *Neisseria gonorrhoeae* and other fastidious microorganisms in in vitro microbiological testing. Its nutrient-rich formulation, including hemoglobin supplements, supports the growth of pathogens that require stringent conditions, making it ideal for identifying gonorrhea and similar infections in clinical or research labs.

• How is the GC Culture Medium supplied, and what preparation is required before use?

  The GC Culture Medium is supplied as a dehydrated powder, meaning it must be reconstituted with sterile water or broth before use. This preparation step is necessary to create a usable culture medium for isolating pathogens, following standard microbiological protocols.

• Is the GC Culture Medium intended for single-use or can it be reused?

  The GC Culture Medium is intended for in vitro microbiological testing, and while the dehydrated powder itself is not explicitly labeled as single-use, the reconstituted medium should be used only once per preparation to maintain sterility and prevent contamination. Proper disposal of unused portions is recommended to avoid cross-contamination.

• What storage conditions are critical for maintaining the efficacy of the GC Culture Medium?

  The GC Culture Medium requires adherence to standard microbiological storage protocols to preserve sterility and efficacy. The dehydrated powder should be stored in a dry, cool environment, away from direct light and moisture, until reconstitution. Once prepared, the medium must be used promptly and under aseptic conditions to prevent degradation or contamination.

• How was the regulatory pathway for the GC Culture Medium determined?

  The GC Culture Medium was cleared through the FDA’s 510(k) pathway, specifically under a *Traditional* review process. It was determined to be *Substantially Equivalent* to a predicate device and falls under the *Microbiology* advisory committee (MI) classification, with a product code of *JTY* and regulation number *866.2410*. This classification aligns with its use as a culture medium for isolating pathogenic Neisseria.