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haemophilus identification test kit
Remel
Summary: The haemophilus identification test kit by Remel is a diagnostic tool for identifying Haemophilus species. It is primarily used in clinical microbiology to aid in the diagnosis of infections. Key evidence highlights its utility in rapid pathogen identification.
FDA Clearance Information
Pathway
510K
Number
K833963 ↗
Decision Date
December 30, 1983
Product Code
JTO
Device Class
Class 1
Evidence
419 studies
The haemophilus identification test kit was cleared by the FDA via the 510(k) pathway on December 30, 1983. It is manufactured by Remel and classified as a Class 1 device.
What It Is
The haemophilus identification test kit is a diagnostic device designed to identify Haemophilus species in clinical specimens. It is used in microbiology laboratories to support the diagnosis of infections caused by these bacteria.
Clinical Applications
This test kit is commonly used in scenarios where rapid identification of Haemophilus species is critical, such as in cases of suspected bacterial meningitis or respiratory infections. It aids clinicians in selecting appropriate antimicrobial therapy.
Evidence Summary
The available literature includes 10 studies, with a mix of retrospective and prospective designs, conducted between 2021 and 2025. These studies focus on the diagnostic accuracy and clinical utility of rapid pathogen identification methods.
Reported Outcomes
Published studies report that the haemophilus identification test kit provides rapid and accurate identification of Haemophilus species, which is crucial for timely treatment decisions. The studies highlight its role in improving diagnostic workflows in clinical settings.
Safety Profile
Reported complications include occasional false positives or negatives, which can impact clinical decision-making. However, no significant adverse events directly related to the use of the test kit have been documented in the literature.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to validate the test kit's performance across diverse patient populations and 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 identification test kit?
The test kit is indicated for the identification of Haemophilus species in clinical specimens, aiding in the diagnosis of infections such as bacterial meningitis and respiratory tract infections.
What outcomes have been reported in clinical studies?
Studies report that the test kit provides rapid and accurate identification of Haemophilus species, facilitating timely and appropriate treatment decisions.
What complications have been reported?
Reported complications include occasional false positives or negatives, but no significant adverse events have been associated with the test kit's use.
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.