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Anti-Coccidioides Cont. Ser. (Mycelial)

by I M, Inc. 510(k)

Active United States

510(k) K760834

Overview

Anti-Coccidioides Cont. Ser. (Mycelial) is a serological reagent device consisting of antigens and antisera used in serological tests to identify antibodies to Coccidioides immitis in serum. It is classified as a Class 2 device under the product code GMH and is intended for microbiology laboratory use.

The device is supplied as a continuous series and is regulated under FDA 510(k) clearance with K760834. It is manufactured by I M, Inc. and is not represented as MRI safe. The device is not specified as single-use or reusable, and no information regarding sterility or storage conditions is provided in the data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760834 Date1 Nov 1976ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GMH
Device Class
Class II
Regulation
21 CFR Part 866.3135
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Anti-Coccidioides Cont. Ser. (Mycelial) used for?

    This serological reagent is used in microbiology laboratories to identify antibodies to Coccidioides immitis in serum samples through serological tests. It contains antigens and antisera specifically designed for this purpose.

  • How is the Anti-Coccidioides Cont. Ser. (Mycelial) supplied?

    The device is supplied as a continuous series, though specific packaging quantities or formats are not detailed in the provided information. It is manufactured by I M, Inc. and is intended for professional laboratory use only.

  • Is the Anti-Coccidioides Cont. Ser. (Mycelial) single-use or reusable?

    The device data does not specify whether this product is single-use or reusable. No information regarding sterility status or storage conditions is provided in the available specifications.

  • What is the regulatory status of this device?

    This device is classified as a Class 2 medical device under product code GMH and has received FDA 510(k) clearance with number K760834. It is regulated under the FDA's traditional clearance pathway and is not represented as MRI safe.