đź“‹ FDA Reference

haemophilus id quad-plate

Gibco Laboratories Life Technologies

Summary: The Haemophilus ID Quad-Plate is a diagnostic tool used to identify Haemophilus species. It is primarily used by microbiologists and laboratory technicians in clinical settings.

FDA Clearance Information

Pathway 510K
Decision Date April 17, 1984
Product Code JSI
Device Class Class 1
Evidence 419 studies

The Haemophilus ID Quad-Plate was cleared through the FDA 510(k) pathway on April 17, 1984. Manufactured by Gibco Laboratories Life Technologies, it is classified as a Class 1 device.

What It Is

The Haemophilus ID Quad-Plate is a culture medium designed to facilitate the identification of Haemophilus species, which are significant in respiratory infections. The quad-plate format allows for the simultaneous testing of multiple samples, enhancing laboratory efficiency. It works by providing necessary growth factors and conditions that support the growth of Haemophilus bacteria, allowing for their identification based on colony morphology and biochemical reactions.

Clinical Applications

This device is commonly used in clinical microbiology laboratories for the identification of Haemophilus species in patient samples. It is particularly useful in diagnosing respiratory tract infections, especially in pediatric and immunocompromised populations. The device is utilized in hospital laboratories and reference labs where accurate and rapid identification of pathogens is critical for patient management.

Indications for Use

The FDA indications suggest that this device is used for identifying Haemophilus species in clinical specimens. It is intended for use in diagnosing infections caused by these bacteria, which can include respiratory tract infections and other systemic infections.

Practical Considerations

The Haemophilus ID Quad-Plate is typically compatible with standard laboratory incubators and requires careful handling to avoid contamination. It is important to follow the manufacturer's instructions for optimal growth conditions and accurate results.

Linked Studies (20)

PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

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PubMed • 2025

Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.

Clinical chemistry and laboratory medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical progress note: Haemophilus influenzae type b.

Journal of hospital medicine

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PubMed • 2025

Pilot study of social media promotion of home-based self-testing for syphilis.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.

Journal of clinical microbiology

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PubMed • 2025

Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.

Florida public health review

View Source →
PubMed • 2025

Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.

Frontiers in cellular and infection microbiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.

Transboundary and emerging diseases

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PubMed • 2025

Tp40: a new potential prognostic and diagnostic marker for syphilis.

Microbiology spectrum

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PubMed • 2025

Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.

The Journal of clinical investigation

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PubMed • 2025

Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.

Hellenic journal of nuclear medicine

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PubMed • 2025

Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.

Biochemistry and cell biology = Biochimie et biologie cellulaire

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PubMed • 2025

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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PubMed • 2025

Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.

Journal of Yeungnam medical science

RCT View Source →
PubMed • 2025

pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.

Magnetic resonance in medicine

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PubMed • 2025

Comparative connectomics of Drosophila descending and ascending neurons.

Nature

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PubMed • 2025

Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

View Source →
PubMed • 2025

History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.

Zeitschrift fur Rheumatologie

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PubMed • 2025

A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.

BioMed research international

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Frequently Asked Questions

What is Haemophilus ID Quad-Plate used for?

It is used for the identification of Haemophilus species in clinical specimens, aiding in the diagnosis of infections caused by these bacteria.

What specialties typically use this device?

Microbiologists and laboratory technicians in clinical microbiology laboratories typically use this device.

What are the FDA-cleared indications?

The device is indicated for the identification of Haemophilus species in clinical specimens, particularly for diagnosing infections caused by these bacteria.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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