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haemophilus id plate
Granite Diagnostics
Summary: The Haemophilus ID Plate by Granite Diagnostics is a diagnostic device cleared by the FDA for identifying Haemophilus species. Key evidence includes studies on antimicrobial resistance and clinical isolation of related species.
FDA Clearance Information
Pathway
510K
Number
K822377 ↗
Decision Date
August 25, 1982
Product Code
JSH
Device Class
Class 1
Evidence
419 studies
The Haemophilus ID Plate was cleared through the FDA 510(k) pathway on August 25, 1982. Manufactured by Granite Diagnostics, it is classified as a Class 1 device under product code JSH.
What It Is
The Haemophilus ID Plate is a diagnostic tool designed to identify Haemophilus species in clinical samples. It is used in laboratory settings to aid in the diagnosis of infections caused by these bacteria.
Clinical Applications
Commonly used in microbiology labs, the Haemophilus ID Plate assists in diagnosing infections by identifying Haemophilus species, which can cause respiratory and systemic infections.
Evidence Summary
The available literature includes three studies, with publication years ranging from 2006 to 2021. These studies focus on antimicrobial resistance and the isolation of related bacterial species.
Reported Outcomes
Published studies report the identification of a multiple drug-resistance gene island in Haemophilus parasuis and the first isolation of Dysgonomonas mossii from a clinical sample. These findings highlight the diagnostic utility of the device in identifying resistant strains and rare bacterial species.
Safety Profile
Reported complications include the potential for misidentification of bacterial species due to overlapping phenotypic characteristics. No direct adverse events related to the use of the device were reported in the studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent clinical trials directly evaluating the device's performance. Further research is needed to assess its efficacy in diverse clinical settings.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
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
RCT|prospective|retrospective|case Series|other View Source →
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
View Source →
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
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
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
View Source →
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
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
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
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Haemophilus ID Plate?
The device is indicated for the identification of Haemophilus species in clinical samples, aiding in the diagnosis of related infections.
What outcomes have been reported in clinical studies?
Studies have reported the identification of drug-resistant Haemophilus strains and the isolation of rare bacterial species.
What complications have been reported?
Safety data indicate potential misidentification issues due to phenotypic similarities among bacterial species.
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.