Fluoroslide Pneumocystis Carinii (IFA) Assay

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

510(k) Number

K884047 ↗

FDA Product Code

LYF

Device Class

Class II

Regulation

21 CFR Part 866.3780

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K881709 Active Cleared 8 Jul 1988

• Modified Ddi Serocard Toxoplasma Igg Test Kit

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  FDA 510(k) K884249 Active Cleared 10 Apr 1989

• Immunocard Hcg II-S Test Kit

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• Modified Ddi Serocard Cmv Igg Test Kit

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• Immunocard Strep a Test

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  FDA 510(k) K896109 Active Cleared 29 Nov 1989

• Modified Ddi Serocard Rubella Igg Test Kit

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  FDA 510(k) K884247 Active Cleared 10 Apr 1989

See all devices from Disease Detection International, Inc. →

• What is the Fluoroslide Pneumocystis Carinii (IFA) Assay used for?

  The Fluoroslide Pneumocystis Carinii (IFA) Assay is an immunofluorescent reagent used to identify Pneumocystis carinii from clinical specimens, aiding in the diagnosis of Pneumocystis carinii infection in laboratory settings.

• How is the Fluoroslide Pneumocystis Carinii (IFA) Assay supplied and intended for use?

  The device is supplied as a reagent kit for in vitro diagnostic use and is intended for use in laboratory settings to aid in the diagnosis of Pneumocystis carinii infection from clinical specimens.

• What regulatory clearance does the Fluoroslide Pneumocystis Carinii (IFA) Assay have?

  The Fluoroslide Pneumocystis Carinii (IFA) Assay received FDA 510(k) clearance (K884047) on March 14, 1989, and is classified as a Class II medical device under the Microbiology specialty with product code LYF.