Wellcolex Colour Salmonella Test ZL 50

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

510(k) Number

K890146 ↗

FDA Product Code

GRM

Device Class

Class II

Regulation

21 CFR Part 866.3550

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Streptex Acid Extraction Kit

  Class I

  FDA 510(k) K910797 Active Cleared 29 Mar 1991

• Wellcogen H. Influenzal ZL21

  Class I

  FDA 510(k) K833077 Active Cleared 10 Jan 1984

• Wellcogen Bacterial Antigen Kit

  Class II

  FDA 510(k) K854852 Active Cleared 4 Feb 1986

• Fibri-Prest Automate HA34 Open recall

  Class II

  FDA 510(k) K840211 Active Cleared 2 Mar 1984

• Streptex Direct a ZL14

  Class I

  FDA 510(k) K842827 Active Cleared 16 Aug 1984

• Diacrom * Atiii

  Class II

  FDA 510(k) K832592 Active Cleared 29 Sep 1983

See all devices from Wellcome Diagnostics →

• What is the Wellcolex Colour Salmonella Test ZL 50 used for?

  The Wellcolex Colour Salmonella Test ZL 50 is designed for the presumptive identification of *Salmonella* species from cultured bacterial isolates in clinical microbiology laboratories. It uses latex agglutination technology with specific antisera to differentiate *Salmonella* from non-*Salmonella* bacteria, helping to expedite diagnostic workflows and reduce turnaround time.

• How is the Wellcolex Colour Salmonella Test ZL 50 supplied, and is it single-use?

  The test is supplied as a ready-to-use kit, meaning no additional preparation is required beyond standard laboratory practices. According to manufacturer specifications, it is intended for single-use per test, ensuring consistency and minimizing cross-contamination risks.

• Does the Wellcolex Colour Salmonella Test ZL 50 require sterilization beyond standard lab practices?

  No additional sterilization is required beyond routine laboratory hygiene protocols. The test is designed for in vitro diagnostic use, and its ready-to-use format eliminates the need for extra sterilization steps, simplifying handling and reducing procedural complexity.

• What regulatory clearance does the Wellcolex Colour Salmonella Test ZL 50 hold?

  The device holds a 510(k) clearance (K890146) from the FDA under the Traditional clearance type, classified as a Class II medical device. This clearance confirms its substantial equivalence to a predicate device for microbiological applications, specifically for serological reagents targeting *Salmonella* spp.

• Are there specific storage or shelf-life instructions provided for this test?

  The provided data does not specify exact storage conditions or shelf life for the Wellcolex Colour Salmonella Test ZL 50. However, adherence to the manufacturer’s guidelines is strongly recommended to ensure optimal performance and reliability of the test results.