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Salmonella O Grouping Antisera Set

by S.M.I. Medical, Inc.

510(k) K912791

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK912791 Date5 Oct 1992ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GRM
Device Class
Class II
Regulation
21 CFR Part 866.3550
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Salmonella O Grouping Antisera Set is a diagnostic reagent designed for the serological identification and grouping of Salmonella species. It comprises antisera that facilitate the determination of Salmonella O antigens, enabling laboratory confirmation of bacterial serogroups through agglutination testing.

This set is intended for use in microbiology laboratories and is supplied as a non-sterile, single-use diagnostic tool. The device is classified as Class II under FDA regulations and holds a 510(k) clearance (K912791) for substantial equivalence in microbiology applications. Storage and handling follow standard laboratory protocols for antisera, and no MRI safety considerations apply.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Salmonella O Grouping Antisera Set used for in a clinical setting?

    The Salmonella O Grouping Antisera Set is designed for serological identification and grouping of *Salmonella* species in microbiology laboratories. It helps confirm bacterial serogroups through agglutination testing, aiding in accurate bacterial classification for diagnostic purposes.

  • Is this product sterile, and how many times can it be used?

    The Salmonella O Grouping Antisera Set is non-sterile and intended for single-use only. Since it is a diagnostic reagent, reuse could compromise accuracy and introduce contamination risks.

  • What storage conditions should be followed for this product?

    Storage follows standard laboratory protocols for antisera. While exact conditions aren’t specified, it should be kept refrigerated (typically 2–8°C) and protected from light, per typical antisera handling guidelines.

  • Does this device require any special handling or safety precautions?

    No MRI safety considerations apply, as this is a laboratory reagent, not a medical implant or device exposed to magnetic fields. Standard laboratory biosafety practices (e.g., proper disposal of biohazardous waste) should be followed.

  • How was this device’s regulatory pathway determined, and what does that mean for buyers?

    The device holds a 510(k) clearance (K912791) under FDA’s Traditional 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device in microbiology applications. This means it meets FDA standards for safety and effectiveness as a Class II diagnostic tool.